Comparison of Open Hemorrhoidectomy under Local and Spinal Anesthesia and its Practical Feasibility at a Tertiary Care Institute

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1 DOI: /SUR/2016/18 Original Article Comparison of Open Hemorrhoidectomy under Local and Spinal Anesthesia and its Practical Feasibility at a Tertiary Care Institute Praveen Singh Baghel 1, Maneesh Joleya 1, Seema Suryavanshi 2 1 Assistant Professor, Department of Surgery, NSCB Medical College, Jabalpur, Madhya Pradesh, India, 2 Associate Professor, Department of Surgery, NSCB Medical College, Jabalpur, Madhya Pradesh, India, Abstract Background: There are various modalities of treatment available for management of hemorrhoids ranging from conservative measures including dietary measures, sclerotherapy to surgical techniques including band ligation, excision. Appropriate modality should be tailored on individual basis. Objective: To compare the results with those after open hemorrhoidectomy performed under spinal anesthesia (SA) and local anesthesia (LA). Methods: Present randomized controlled trail was carried out in the Department of Surgery, N.S.C.B. Medical College, Jabalpur, 24 cases with hemorrhoids. Cases were randomized with a help of randomization sequence generated with a help of statistician into either local or under SA group. Results: Mean visual analog scale (VAS) score signifi cantly low at 90 min and 6 h in LA group. Post-operative complications such as hypotension, urinary retention, and bleeding are not found in both groups except headache which is signifi cant in SA group. Post-operative hospital stays signifi cantly low in LA group. Conclusion: Open Milligan Morgan hemorrhoidectomy is feasible under LA. Post-operative outcomes are better under LA in terms of pain, bladder evacuation, hospital stay and cost effectiveness with comparable complications. Keywords: Hemmorhoids, Local anesthesia, Milligan Morgan, Spinal anesthesia INTRODUCTION Hemmorhoids are abnormal symptomatic masses of thickened sub-mucosal tissue containing blood vessels, smooth muscles, elastic and connective tissues. It is the most frequent anorectal surgical problem in routine practice. There are various modalities of treatment available for management of hemorrhoids ranging from conservative measures including dietary measures, sclerotherapy to surgical techniques including band ligation, excision. Appropriate modality should be tailored on individual basis. 1 It has been observed that Access this article online Month of Submission : Month of Peer Review : Month of Acceptance : Month of Publishing : many of the patients taking conservative management experience recurrences and relapses of bleeding PR and relapsing episodes of hemorrhoids, once they discontinue the treatment. Many of these patients willing for surgical intervention are reluctant because of complications and prolonged stay at hospital due to regional or general anesthesia (GA). Surgical techniques involving excision of hemorrhoids are routinely carried out under regional or GA. 2 In the modern surgical practice, economic and social pressures are compelling surgeons to modify their practice and increasing number of procedures are being carried out on outpatient basis. There has been a strong trend toward day care and office procedures for treatment of hemorrhoids also keeping in view cost effectiveness, better patient satisfaction and reducing other side effects. Patient s compliance of treatment is associated with shorter hospital stay, less morbidity, early return to work and the pain associated with the procedure. In surgical techniques, ligation excision hemorrhoidectomy described by Milligan Morgan is Corresponding Author: Dr. Seema Suryavanshi, Netaji Subhash Chandra Bose Medical College, Jabalpur, Madhya Pradesh, India. Phone: aaradhya1310@gmail.com IJSS Journal of Surgery March-April 2016 Volume 2 Issue 2 53

2 the time-tested procedure. It is traditionally viewed as a painful procedure. 3 Most operations are done under GA or regional anesthesia which are associated with side effects like nausea, vomiting, hypotension, urinary retention, and prolonging hospital stay. Prolonged hospital stay and absence from work place also imposes a financial burden. Improvements in multimodal and preemptive analgesia, introduction of stapled anopexy and improvements in patient counseling have led to an increasing number of day care hemorrhoidectomies. A further evolution in this technique is open hemorrhoidectomy under local anesthesia (LA). 2 Bansal et al. concluded in their study that LA is an alternative mode of anesthesia surgeons can safely carry out at their own while performing open hemorrhoidectomy. It was associated with a shorter hospital stay, low pain scores, and lower postoperative complications; supporting routine use of LA for hemorrhoidectomy. 2 Alatise et al. concluded that immediate post-operative pain control and patient s comfort in immediate post-operative pain improved by continued effect of the LA and pre-operative analgesia; along with the presence of adrenaline with lignocaine also reduces the bleeding intraoperatively. 4 Kushwaha et al. in their study concluded hemorrhoidectomy under LA associated with a shorter hospital stay and lower costs along with similar pain and satisfaction scores after procedures done under regional and GA. 5 Foo et al. concluded that anorectal surgery can be performed on an ambulatory basis with safety and efficacy. In addition, there may be potential benefit in a decreased incidence of urinary retention. There is also substantial cost savings. 6 In our scenario also, hemorrhoid is a common presentation and disease refractory to conservative management and Grades 3 and 4 requiring surgical ligation excision are avoided for surgery because of patient s apprehension related to regional and GA. Many of the patients attending our out-patient department (OPD) belong to lower socio-economic strata are also concerned about hospital stay and loss of working days. Keeping in view, above mentioned factors and worldwide changing trends in favor of day care surgeries, we prospectively evaluated the feasibility of open hemorrhoidectomy under LA and its comparison with procedure done under spinal anesthesia (SA) in terms of post-operative pain, hospital stay, cost effectiveness and other complications. METHODS After the ethical approval from the Institutional Ethical Committee, the present randomized controlled trail was carried out in the Department of Surgery, N.S.C.B. Medical College, Jabalpur. 24 cases with hemorrhoids, inclusion criteria: (A) Patients with Grade 3 and Grade 4 hemorrhoids and consenting to participate, (B) patients with 2 hemorrhoids not responding to conservative management, (C) with no allergy to lignocaine and bupivacaine. Exclusion criteria: (i) Patients with associated anorectal abscess, (ii) patients who had symptoms of benign prostatic hypertrophy or bladder neck obstruction, (iii) patients with the neuro-psychotic disorder, (iv) patients unfit for surgery (e.g. coagulopathy or liver cirrhosis), (v) patients on aspirin (can be taken after discontinuation). Once the cases fulfilled the inclusion and exclusion criterion, a written informed consent was taken, and cases were randomized with a help of randomization sequence generated with a help of statistician into either local or under SA group. Drug Used Lignocaine 2% with adrenaline 1:100,000 dilutions for local infiltration. While going through literature review, we came across the study done by Bansal et al. 2 where they used a cocktail mixture of bupivacaine 0.5% with adrenaline and lignocaine 2% in equal amounts. But due to non-availability of bupivacaine 0.5% with adrenaline at our institute we preferred to use lignocaine 2% with adrenaline. The maximum amount of infiltration needed to produce the effect was 20 ml varying according to number and location of hemorrhoids. Other material used was needles of 22 G and 25 G to infiltrate intersphincteric plane and perianal skin respectively. Lignocaine 2% jelly for packing and local application on discharge. Open hemorrhoidectomy was performed by the standard Milligan Morgan technique. After hemorrhoidectomy, 2% lignocaine jelly was applied locally, and a standard dry dressing was done followed by keeping a pack soaked with lignocaine jelly. Patients were kept under observation for at least 24 h and were allowed to take tramadol for pain on as and when required basis and different observations were made at fixed intervals of time. On discharge patients were prescribed lignocaine 2% for local application, oral tramadol, ciprofloxacin and metronidazole combination along with syrup lactulose and hot sitz bath. Furthermore, patients were counseled for side effects like reactionary bleed infection, etc. Patients were observed at fixed time interval on followup on the 5th day, week 2 and week 4 either personally or on telephone. Post-operative outcomes after surgery were observed in terms of following factors: First 24 h, (A) Visual analog scale (VAS) scores at 0 min, 30 min, 60 min, 90 min, 6 h and 24 h, (B) number of tablets of tramadol taken in 24 h, (C) time of passing first urine postoperatively, (D) post-operative hypotension defined as fall in systolic blood pressure (SBP) >20 mm Hg, (E) any headache or bleeding observed. During follow-up period at day 5, 2- and 4-weeks, (A) Hemorrhage, (B) infection, (C) recurrence. Statistical Analysis The data collected were entered in Microsoft excel The data were analyzed using Epi-info software. The quantitative data was summarized as mean and 54 IJSS Journal of Surgery March-April 2016 Volume 2 Issue 2

3 standard deviation, while qualitative data as percentage and proportion. To show the association and difference between two independent categorical variables, Chi-square test and in continuous variable Student s t-test would be applied. We will consider the statistical test to be significant when the P < RESULTS A total of 24 patients were operated for open Milligan Morgan hemmorrhoidectomy in the study, out of which 13 of the patients were operated under LA and 11 were operated under SA. The age of patients operated ranged from 20 to 75 years and distribution was statistically comparable with P value for age distribution among both groups being >0.05 which was not significant statistically. The mean age of patients operated under LA was years and that for patients operated under SA being years. Out of the 13 patients operated under LA, 5 were males and 8 were females, out of 11 patients operated under SA, all were males and no female was there in this group. The various grades of hemorrhoids operated were internal from Grades 2 to 4 and external ones. Those in LA were 6 with Grade 2, 5 with Grades 3 and 2 with external hemorrhoids. No patient with Grade 4 was operated in LA. Those in SA were 5 with Grade 2, 3 with Grade 3 and 3 with Grade 4. No patient with external hemorrhoids was operated under SA. The P value for this difference in grades of hemorrhoids was calculated to be 0.14 and hence not significant. The mean VAS score calculated for the patients operated under LA and SA at various time intervals of observation viz. 0 min, 30 min, 60 min, 90 min, 6 h and 24 h was lower at alltime intervals of observation in patients operated under LA. The statistical significance of lower VAS score was found at time 90 min and 6 h with P value being and (Table 1). Patients were allowed to take tablet tramadol on as and when required basis for alleviation of pain. A total number of tramadol tablets taken were noted at the end of 24 h. Out of 13 patients operated under LA, 07 took tablet tramadol for pain alleviation in first 24 h and out of those 11 in SA group 09 took tramadol tablet for pain relief. Chi-square statistics for this difference was 2.09 and P value found to be 0.14, Table 1: Mean visual analogue scores Time since Operated Operated P value surgery under LA under SA 0 min min min min h h LA: Local anesthesia, SA: Spinal anesthesia which was statistically not significant. Average number of tramadol tablets taken by each group of patients in first 24 h was 0.69 and 1.27 respectively in LA and SA group. The P value for this difference was P < 0.04 which was statistically significant, i.e., a significant large number of tramadol tablets were consumed by patients in SA group as compared to LA group. The mean time interval at which patient first evacuated his bladder after surgery was observed to be min for patients under LA group and that for patients under SA group was min (1 h 50 min). This time interval difference was statistically significant (P = 0.002). The mean post-operative stay at hospital was observed to be 1 day for patients operated under LA and those who were operated under SA had a mean post-operative stay at hospital to be 2.63 days. Statistically this difference was evaluated by applying Student s t-test and the P value was found to be and hence the difference in post-operative stay in both groups was statistically significant. This is one of the most significant observations validating the feasibility of open Milligan Morgan hemorrhoidectomy under LA as a day care surgery permitting early ambulation of patient. Immediate post-operative complication following open Milligan Morgan hemmorrhoidectomy was observed within first 24 h in terms of hypotension, headache, bleeding and transient fecal incontinence. Only headache was observed as a complication in 3 out of 11 patient operated under SA while no complication was reported among patients operated under LA. Headache as a complication was studied for statistical significance between both groups by using Chi-square test where Chi-square statistics was found to be 4.05 and P value being The difference was significant statistically. During follow-up period patients were observed on day 5, 2nd week and 4 th week post-operatively for the presence of hemorrhage, infection, and recurrence. 1 out of 13 patients operated under LA and 3 out of 11 patients operated under SA were observed to be having infection on day 5. No other complication was noted in follow-up period in any patient of either group. The occurrence of infection in patients operated under LA and those operated under SA was compared using Chi-square test and Chi-square statistics for the same was found to be 4.6 and P value being Hence, difference in infection incidence in follow-up period was not significant statistically. DISCUSSION Hemorrhoids are a common presentation in surgery OPDs. There are various modalities for treatment of hemorrhoids ranging from conservative dietary and life style change to involving use of sclerosant, band ligation and surgery being. IJSS Journal of Surgery March-April 2016 Volume 2 Issue 2 55

4 Open Milligan Morgan hemorrhoidectomy has been viewed as gold standard procedure. Surgery for hemorrhoids involves manipulation over sensitive anoderm which is rich in nerve endings. Several possible ways of reducing pain and discomfort have been proposed, including the use of multimodal analgesics, restricting surgery to one hemorrhoid at a time, avoiding a closed technique, preemptive analgesia, caudal block, pre-operative lactulose, pudendal, perineal blocks. 2 Stapled anopexy is however associated with fecal urgency, tenesmus, and pain, and instances of rectal perforation and bleeding have been reported. 7 Open hemmorrhoidectomy continues to remain a safe way of excising hemorrhoids. In developing different techniques for surgical treatment of hemorrhoids, pain control, patient satisfaction with the procedure and lack of complications are primary determinants of feasibility in a day-care unit, with hospital stay time and cost being secondary determinants. 5 Daycase surgery has expanded remarkably in the developed countries, and many general surgical operations can safely be done as day care procedures. Hemmorrhoidectomy can be performed under GA; however, there may be the complications resulting from GA together with associated diseases in advanced age for, e.g. aspiration pneumonitis. Caudal or SA has been used as an alternative to GA for hemorrhoid surgery, but they all require a trained anesthetist and have numerous known complications. Spinal or caudal anesthesia and pudendal (ischiorectal) nerve blocks may cause urinary retention, with a reported incidence of between 10% and 17%. 2 LA with perianal and anal canal blocks gives adequate duration and depth of anesthesia and results in excellent relaxation of the anal canal. 6 Lignocaine provides excellent initial pain relief, and adrenaline reduces bleeding in the operative field due to vasoconstriction. Lignocaine with adrenaline provides enough time for not only hemmorrhoidectomy but also transportation to home. 8 In a study by Bansal et al., it was concluded that hemmorrhoidectomy under LA was associated with a shorter hospital stay, lower pain scores, and lower post-operative complications, which supports the routine use of LA for hemmorrhoidectomy. 2 In another study by Kushwah et al., it was concluded that open hemorrhoidectomy under LA was associated with a shorter hospital stay and lower costs. These outcomes, combined with the finding of similar pain and satisfaction scores after both procedures, support the routine use of LA for hemorrhoidectomy. 5 Another study by Alatise et al., 4 suggested that surgeries done under LA have some important advantages. These advantages include early ambulation and subsequent discharge from the hospital, reduction in total cost of the procedure and it encourages doctor patients interaction during the procedure. This study further corroborated the fact that hemorrhoidectomy under LA is not only well tolerated but practicable and feasible. Low total cost of the procedure and assurance of being awake during the procedure enhanced patients acceptability of surgery. Adequate pain control can be achieved with the use of LA when patients are medically fit and psychologically prepared for the procedure. The presence of adrenaline in the lignocaine may also be helpful to reduce intraoperative bleeding which was observed during the procedure. The complication rates found in this study were no other different from those found in other studies. A study of 51 patients at University Hospital, Brazil, in which outpatient hemorrhoidectomy was carried out under LA concluded that late complications did not differ significantly and the estimated hospital costs were much lower. 9 Another study from Colorectal Surgery Unit, Linköping University Hospital, Sweden, in which 30 consecutive patients with proctologic disorders consented to ambulatory (n = 29) or hospitalized (n = 1) operation with local perianal block concludes that the perianal block is easy to apply and effective as a sole method of anesthesia for proctologic operations. 10 In our current study, we took 24 patients and allocated them to LA and SA group pre-operatively with 13 being done in LA and 11 were being done under SA. The local anesthetic mixture applied intersphincterically and infiltrated under perianal skin provided sufficient time to carry out open Milligan Morgan hemorrhoidectomy under LA. Patients accepted it well with better postoperative experience and earlier ambulation. Hence in our study open Milligan Morgan hemorrhoidectomy was completely feasible and acceptable to patients. Mean VAS Scores Among LA group patients mean VAS scores were lower at all-time intervals of observation post-surgery as compared to that in SA group patient with statistically significant at 90 min and 6 h duration post-surgery. These results were similar to those found in the study Bansal et al. where they found statistically significant lower pain scores at 6 h. 2 In the study done by Kushwah et al. 5 pain scores were higher in LA group at 90 min as compared with the group operated under GA. This variation was in concordance with the terminal half-life of Lignocaine. In study by Alatise et al. 4 maximum patients had a little but tolerable discomfort during the procedure being carried out under LA. Although none of the patient had an excellent analgesia nor excessive discomfort. In our study, too mean VAS scores were relatively higher at 90-min interval and the need of tramadol tablet was also observed by some patient for analgesia maximum being at 90 min time interval which is in support of the observation of Kushwah et al. 5 Post-operative Analgesia It was graded as excellent in 90% of LA group patients and 50% in SA group patients in the study by Bansal et al IJSS Journal of Surgery March-April 2016 Volume 2 Issue 2

5 Post-operative analgesia was evaluated in terms of tablets of tramadol taken within first 24 h. In LA group 7 out of 13 and in SA group 9 out of 11 patients took tramadol in first 24 h for pain relief in our study. Although this difference was not significant statistically, based on this the post-operative pain could be graded as mild in LA group and moderate in SA group. Hence, better postoperative analgesia was achieved in LA group in the first 24 h. This was also corroborative with that found in the study by Bansal et al. 2 Mean Time of Bladder Evacuation After Surgery It was significantly earlier in patients operated under LA group (53 min) as compared to those operated under SA group (109 min) with P value being This was mainly due to lack of bladder atony in the case of LA and reduced fluid requirement for patients operated under LA as compared to those operated under SA. This also allowed earlier ambulation of patients operated under LA. Similar observation of earlier bladder evacuation in LA group (1.5 ± 1.12 h) versus SA group (8.12 ± 4.17 h) P value being <0.001 was found in the study done by Bansal et al. 2 In a study by Alatise et al. 2 out of 22 patients operated under LA experienced urinary retention. 4 Mean Post-operative Stay It was strikingly lower in patients of LA group. In LA group patients it was 1 day as compared to 2.63 days in SA group patients with a P = In Bansal et al. mean post-operative stays were in LA group 6.08 ± 0.27 h and in SA group ± 11.7 h with P < The similar findings were observed during study by Kushwah et al. in their studies. This was significant in terms of earlier discharge, earlier return to work and brief hospital in stay. 5 In study by Alatise et al. 4 although no exact quantitative data in terms of post-operative stay was reported, but early ambulation and discharge were mentioned in this study also corroborating with findings of studies by Bansal et al. 2 and Kushwah et al. 5 Hence LA can aptly be given for open hemorrhoidectomy on day care basis. Post-operative Complications In immediate post-operative period headache was observed in 3 out of 11 SA group patients and none of the patients among LA group patients with P = 0.04 hence significant. 1 out of 13 in LA group and 3 out of 11 patients in SA group had infection of local wound on day 5 of post-operative period. The difference in these complications was not significant statistically. All of these patients were prescribed Metrogyl-P ointment for local application to combat infection and infection was resolved well in all patients affected. Headache, post-operative hypotension and bladder retention were expected to occur in SA group patients specifically as was seen in some of the patients in the study by Bansal et al. 2 headache was found in only SA group patients in our study too but no patient observed urinary retention or need for catheterization for bladder evacuation in any of the group despite significantly longer time interval of bladder evacuation post-operatively in SA group patients. Post-operative hypotension defined as fall of more than 20 mm Hg in SBP as compared to baseline SBP of pre-operative period, was not found in any of the patients of either group. This was probably due to sufficient fluid supplementation in SA group patients during intraoperative period. Although a dip in SBP was observed in all patients of SA group at 30 min of time interval after surgery which was managed by proper fluid supplementation. Overall in our study, patients were successfully operated under LA for open Milligan Morgan hemorrhoidectomy. The cocktail mixture of lignocaine with adrenaline allowed sufficient window to carry out the procedure with the adequate relaxation of sphincters. The difference in post-operative pain scores, earlier ambulation, and shorter hospital stay among both groups were significant statistically favoring LA. The post-operative complications did not show any statistically significant difference in both groups. Along with earlier return to work, the reduced demand of fluids, intravenous (IV) antibiotics and other IV medications due to brief hospital stay in LA group patients also resulted in reduced cost of treatment in LA group patients confirming cost effectiveness in LA group patients. CONCLUSION Open Milligan Morgan hemorrhoidectomy is feasible under LA. Post-operative outcomes are better under LA in terms of pain, bladder evacuation, hospital stay and cost effectiveness with comparable complications. REFERENCES 1. Madoff RD, Fl eshman JW, Clinical Practice Committee, American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of hemorrhoids. Gastroenterology 2004;126: Bansal H, Jenaw RK, Mandia R, Yadav R. How to do open hemorrhoidectomy under local anesthesia and its comparison with spinal anesthesia. Indian J Surg 2012;74: Ghassan A, Nasir A. Open haemorrhoidectomy: Modified Milligan Morgan ligation and excision technique. IJGE 2001;1: Alatise OI, Agbakwurul AE, Takure AO, Adisa AO, Akinkuolie AA. Open hemorrhoidectomy under local anesthesia for symptomatichemorrhoids; our experience in Ile-Ife, Nigeria. Afr J Health Sci 2010;17: Kushwaha R, Hutchings W, Davies C, Rao NG. Randomized IJSS Journal of Surgery March-April 2016 Volume 2 Issue 2 57

6 clinical trial comparing day-care open hemorrhoidectomy under local versus general anesthesia. Br J Surg 2008;95: Foo E, Sim R, Lim HY, Chan ST, Ng BK. Ambulatory anorectal surgery Is it feasible locally? Ann Acad Med Singapore 1998;27: Cheetham MJ, Mortensen NJ, Nystrom PO, Kamm MA, Phillips RK. Persistent pain and faecal urgency after stapled haemorrhoidectomy. Lancet 2000;356: Aphinives P. Perianal block for ambulatory hemorrhoidectomy, an easy technique for general surgeon. J Med Assoc Thai 2009;92: Lacerda-Filho A, Cunha-Melo JR. Outpatient haemorrhoidectomy under local anaesthesia. Eur J Surg 1997;163: Nyström PO, Derwinger K, Gerjy R. Local perianal block for anal surgery. Tech Coloproctol 2004;8:23-6. How to cite this article: Baghel PS, Dr Joleya M, Suryavanshi S. Comparison of Open Hemorrhoidectomy under Local and Spinal Anesthesia and its Practical Feasibility at a Tertiary Care Institute. IJSS Journal of Surgery 2016;2(2): Source of Support: Nil, Conflict of Interest: None declared. 58 IJSS Journal of Surgery March-April 2016 Volume 2 Issue 2