Comparative Study of Intrathecal Administration of Bupivacaine Ketamine With Bupivacaine Tramadol In Patients For Non PIH caesarean Section

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1 Original Article: Comparative Study of Intrathecal Administration of Bupivacaine Ketamine With Bupivacaine Tramadol In Patients For Non PIH caesarean Section * Dr. Jamadar N. P, * Dr. Khade Ganesh, ** Dr. Ghuge Sandeep, * Dr. Shiledar Vikram, * Dr. Lanjewar * Dept. of Anesthesia, MIMSR Medical College, Latur, Maharashtra, India ** Dept. of Physiology, MIMSR Medical College, Latur, Maharashtra, India Corresponding author: Dr. Sandeep Ghuge Abstract: Introduction: In pursuit of relief of pain, particularly pain during and after surgery, many attempts have been made since time immemorial. The purpose of this study was to compare the onset and duration of sensory and motor block, duration of analgesia as well as the hemodynamic changes and complications following intrathecal bupivacaine supplemented with either ketamine or tramadol. Material and method: In a prospective, double-blind study, 80 patients undergoing non PIH caesarean section under spinal anaesthesia were randomly allocated to one of two groups. Group K received 9 mg of hyperbaric bupiva-caine + 25 mg ketamine, group T received 9 mg of bupivacaine + 20 mg of tramadol. Patients in groups K achieved highest sensory level more rapidly in 4.14 ± 1.15 min than group T 7.62 ± Duration of analgesia was more in group T ( ± 6.54 min) than in group K ( ± min). Hemodynamic stability was better with group K. Conclusion: Compared to intrathecal ketamine 25mg, tramadol 20 mg, as an adjunct to bupivacaine for subarachnoid block for caesarean section, showed a longer duration of analgesia. Ketamine has better hemodynamic stability and achieved highest sensory level in shorter duration than tramadol. Key words: Caesarean Section, Bupivacaine, Ketamine INTRODUCTION: Various drugs have been added to the local anaesthetic agents given intrathecally in an attempt to improve on the analgesic effect of the local anaesthetic agent, as well as the duration of analgesia. Anaesthesia for a pregnant patient is unique in that two patients are cared for simultaneously; the parturient and the foetus. Caesarean section can be performed under general anesthesia. But risk of aspiration of stomach content, drug induced neonatal depression and many problems associated with general anesthesia may largely avoided by using regional anaesthesia technique. Regional anaesthesia is the preferred technique for most of lower abdomen and lower limb surgeries. It allows the patient to remain awake, minimizes or completely avoids the problem associated with airway management. The technique is simple to perform. With spinal anaesthesia, the onset of anaesthesia is more rapid; allowing the surgical incision to be made sooner and also provides postoperative analgesia and less neonatal exposure to potentially depressant drugs. Lignocaine and bupivacaine are the most commonly used local anaesthetic agent for spinal anaesthesia. But they don t provide prolonged postoperative analgesia. 184

2 Hence another adjuvant is required for producing prolonged postoperative analgesia. Intrathecal opioid administration has been demonstrated to provide effective postoperative analgesia after a variety of surgical procedures, albeit at the cost of an increased risk for respiratory depression. 1 Tramadol, in contrast, is a centrally acting analgesic that has minimal respiratory depressant effects, 2, 3 by virtue of its 6000-fold decreased affinity for mu-receptors compared with morphine. 4, 5 It also inhibits serotonin and norepinephrine reuptake in the spinal cord and has no reported neural toxicity. 6 Accordingly, Tramadol has the potential to provide effective postoperative analgesia with no risk of respiratory depression after central neuraxial administration. Intrathecal ketamine has beneficial effect on cardiovascular function and has good analgesic and local anaesthetic effect. The aim of our study was to evaluate the effect of intrathecal ketamine and tramadol in parturient undergoing caesarean section with bupivacaine spinal anesthesia on the onset, duration and recovery of sensory and motor blockade, and to observe the duration of post operative analgesia, the incidence of side effects and cardiovascular effects. MATERIAL AND METHOD: The study was undertaken after obtaining ethical committee clearance as well as informed consent from all patients. 80 female patients, scheduled for caesarian section belonging to ASA class I were included in study. The study population was randomly divided into two groups with 40 patients in each group. Group T: received 1.8cc (9mg) hyperbaric bupivacaine 0.5% +20 mg tramadol (Total 2.3 cc.) Group K: received 1.8cc (9mg) hyperbaric bupivacaine 0.5% + 25 mg ketamine 0.5cc (Total 2.3 cc.) Exclusion criteria: Contraindication to regional anaesthesia Preeclampsia Height less than 150cm or more than 180cm Evidence of foetal compromise Morbidly obese patients After taking history, physical examination and all routine investigation were done. The procedure was explained to each patient. Study medication, randomization, blinding and concealment done. On the day of surgery, patient s basal pulse and basal blood pressure were recorded. A peripheral intravenous line with 18 gauge cannula was secured in one of the upper limbs. Patients were preloaded with 1000 ml of Ringer lactate 30 minutes prior to the scheduled time of surgery and connected to multiparameter monitor which records heart rate, non-invasive measurement of SBP, DBP, MAP, continuous ECG monitoring and oxygen saturation. A subarachnoid puncture was performed in sitting position at L3-4 interspace with 25 gauge quincke point spinal needle. Following injection of the anesthetic mixture of respective group the patients were placed supine immediately with a 20 degree left lateral tilt and 100% O2 3 liter/min was delivered by face mask till delivery of the baby and there after continued with ventimask 2 liter/min. Blood pressure, heart rate, ressspiratory rate and oxygen saturation were recorded at regular interval till the end of surgery. Monitoring was continued into the postoperative period up to 24 hours. The onset of sensory block was assessed by pinprick to skin every 2 minutes till the level stabilized for three 185

3 consecutive tests. Regression time, to reach sensory level two segments from the highest level and regression time to reach sensory level up to T12 was recorded. Onset and duration of motor block was assessed and graded by using described by Bromage. Duration of analgesia was measured as the time from induction of block to first patient request for supplemental analgesia. Presence of side effects mainly hypotension, bradycardia, sedation, nausea & vomiting, pruritus, nystagmus and respiratory depression were noted. Hypotension is defined as reduction of systolic blood pressure less than 90 mmhg or < 30 % of baseline and is treated with increased rate of intravenous fluids and if needed injection mephenteramine 3mg (I.V) given in increments. Bradycardia (<60 beats/min) was treated with injection Atropine 0.6 mg (I.V). Nausea and vomiting were treated with injection Ondansetron. OBSERVATION AND RESULTS: In our study we have selected 80 parturient of ASA group I undergoing caesarean section and divided into two groups, 40 patients in each group. According to mean age in years, mean height and mean weight, there is no statistical significant difference in patients of both groups. Table1: Patients characteristics & duration of surgery Group K Group T P value Age ± ± 6.82 >0.05 Height ± ± 4.52 >0.05 Weight ± ± 3.49 >0.05 Duration of Surgery (minutes) ± ± 3.54 > 0.05 Values are given in mean ± SD. Inference: There is no statistically significant difference in mean age, height and weight and duration of surgery between two groups. (P >0.05) 186

4 Table 2: Changes in heart rate Time Group K Group T P Value Mean ± SD Mean ± SD Basic ± ±4.71 NS 2 Min 104.3± ±3.42 NS 5 Min 98.71± ±4.21 NS 10 Min 97.1± ±1.24 P< Min 91.64± ±1.68 P< Min 88.23± ±2.14 P< Min 84.66± ±3.24 P< Min 78.10± ±5.10 NS 60 Min 74.82± ±3.24 NS 70 Min 71.24± ±2.12 NS 80 Min 78.92± ±1.82 NS 90 Min 81.76± ±2.54 NS Inference: The changes observed in heart rate are statistically significant at 10, 20, 30 and 40 minutes (P< 0.05). Pulse rate remain on higher side in Group K. Table 3: Changes in systolic blood pressure: Time Group K Group T P Value Mean ± SD Mean ± SD Basic ± ±2.10 NS 2 Min ± ±3.25 NS 5 Min 98.52± ±1.65 NS 10 Min 96.24± ±4.26 P< Min 96.46± ±5.25 P< Min 96.08± ±4.45 P< Min ± ±3.45 P< Min ± ±6.48 NS 60 Min ± ±4.63 NS 70 Min ± ±3.45 NS 80 Min ± ±4.16 NS 90 Min ± ±2.56 NS Inference: The changes observed in Systolic blood pressure are statistically significant at 10, 20, 30, 40 minutes (P< 0.05). 187

5 Table 4: Changes in diastolic blood pressure Time Group K Group T P Value Mean ± SD Mean ± SD Basic 78.56± ±4.56 NS 2 Min 74.45± ±3.45 NS 5 Min 70.46± ±2.65 NS 10 Min 68.81± ±3.48 P< Min 65.36± ±4.66 P< Min 64.45± ±5.32 NS 40 Min 66.65± ±3.32 NS 50 Min 68.48± ±3.56 NS 60 Min 68.31± ±2.52 NS 70 Min 70.45± ±5.26 NS 80 Min 72.36± ±3.84 NS 90 Min 74.22± ±3.25 NS Inference: The changes observed in diastolic blood pressure are statistically significant at 10 and 20 minutes (P< 0.05). Table 5: Sensory and motor characteristics Parameter ( minutes) Group K Group T P value Sensory onset (T 10 ) 2.21 ± ± 1.20 > 0.05 Time to achieve Highest level 4.14 ± ± 1.02 < 0.05 of block Sensory regression to T ± ± 4.61 > 0.05 Time to achieve Bromage scale ± ± 2.05 > 0.05 Time to achieve Bromage scale ± ± 5.12 > 0.05 Values are given in mean ± SD. Inference: There is no statistically significant difference in mean time for sensory onset and Sensory regression to T12 between two groups. (P >0.05) But there is statistically significant difference in mean time to achieve highest level of block (p < 0.05) which is less for Group K. 188

6 There is no statistically significant difference in motor blockade characteristics. (p <0.05) Table 6: Duration of Analgesia Group K Group T P value Duration of analgesia (min) ± ± 6.54 < 0.05 Values are given in mean ± SD. Inference: There is statistically significant difference in duration of analgesia which is more in Group K. (p< 0.05) Table 7: Intra operative complications Complication Group K Group T Hypotension 2 6 Bradycardia 1 4 Nausea and vomiting 6 3 Respiratory depression 0 0 Nystagmus 4 0 Inference: Hypotension and bradycardia are more common in Group T while nausea and vomiting are more common in Group K. Respiratory depression is absent in both groups. DISCUSSION The most important advantage of spinal anaesthesia is an awake mother at the time of her child which inadequate cough, susceptible to the development of post operative pulmonary complications. The duration of spinal analgesia can be prolonged by immediately establishes maternal - infant bonding the adjuvants like vasoconstrictors, opioids, and successful breast feeding and lastly but not the least, there is always an option of using intraspinal analgesic for post operative pain relief.uncontrolled post operative pain may produce a range of detrimental acute and chronic effects. The attenuation of peri operative pathophysiology that occurs during surgery through reduction of nociceptive input to the CNS and optimization of perioperative analgesia may decrease complications and facilitate recovery during neostigmine, ketamine, midazolam etc. Intrathecal midazolam produces sedation, ketamine results in psychomotor symptoms and neostigmine causes excessive nausea and vomiting. Most commonly used adjuvants to local anesthetics for spinal anaesthesia are opioids and they have formed a cornerstone option for the treatment of post operative pain. These agents exert their analgesic effects through µ- receptors at spinal and supraspinal level. Tramadol is the immediate post-operative period. 7 Patients with a centrally acting analgesic agent with two distinct poor pain control may breath less deeply, have an mechanisms of action. It binds opioid receptors weakly and inhibits the reuptake of norepinephrine 189

7 and serotonin in the spinal cord. 4, 8 When administered epidurally, tramadol has been demonstrated to provide adequate postoperative analgesia after major abdominal surgery and Caesarean section. 9, 10 Hence we decided to study and compare the effect of intrathecal tramadol and Ketamine as an adjuvant to bupivacaine in a patients undergoing caesarean section. In this study, patients characteristics such as age, height and body weight distribution were similar in both groups. There was no significant difference between surgical time in both the groups. It was ± 5.45 min in group K and ± 3.54 min in group T. Present study showed that the supplementation of 9 mg of spinal bupivacaine with 25 mg ketamine or 20 mg tramadol did not show significant difference in the time for onset of sensory blockade. In both group highest level attained was T6. Time to achieve T4 level is more rapid with group K than group T. It was 4.14 ± 1.15 min in group K and 7.62 ± 1.02 min in group T. Findings are similar to study conducted by Ila Patel, Rachana Ghandhi, et al 11 (2011) who evaluated the effect of intrathecal ketamine on post operative analgesia in non PIH caesarian section. They concluded that onset of sensory block is more rapid by adding ketamine to intrathecal bupivacaine. Heart rate of group K patients remain on higher side than group T. Bradycardia occur in 4 patients of group T and 1 patient in group K. This is advantage of ketamine over tramadol. Difference in systolic pressure of both groups is statistically significant at 10, 20, 30 & 40 minutes and and remain on higher side in group K. Difference in diastolic pressure in both groups is statistically significant at 10 & 20 minute and it remain on higher side in Group K. Findings of this study are similar to the findings reported by Kaliyani Govindan, Rajmani Krishnan, Marc P. Kaufman, et al (2001) 12 who found that due to cardiovascular stimulant action of ketamine, there was a mild rise in heart rate and blood pressure.duration of analgesia is longer with Group K than with Group T which was ± 6.54 min in group K and ± 15.4 min in group T. Dipasriv Bhattacharya, Arnab Banerjee (2004) 13 demonstrated comparative study between intrathecal bupivacaine and intrathecal ketamine. The duration of postoperative analgesia was more with ketamine group than bupivacaine alone, which was significant (P<0.001). Ila Patel, Rachana Ghandhi, et al 11 (2011) evaluated the effect of intrathecal ketamine on post operative analgesia in non PIH caesarian section. They conclude that duration analgesia is longer with intrathecal bupivacaine + intrathecal ketamine than bupivacaine alone but not provide analgesia for longer time. A. Subedi, B.K. Biswas, M. Tripathi et al 14 (2013) studied the analgesic effects of intrathecal tramadol in patients undergoing caesarean section and concluded that Compared to intrathecal fentanyl 10 mcg, tramadol 10 mg, as an adjunct to bupivacaine for subarachnoid block for caesarean section, showed a longer duration of analgesia with a reduced incidence of shivering. Incidence of bradycardia, hypotension are more common in tramadol group while nausea & vomiting, nystagmus are more common in group K. Bion JF (1984)8 said that central effects (drowsiness, dizziness and nystagmus) also occurred with intrathecal ketamine. Ila Patel, Rachana Ghandhi, et al 11 also found that incidence of nausea and vomiting and nystagmus was more with ketamine group. 190

8 Incidence of nausea and vomiting and nystagmus is more with group-b. CONCLUSION: We have concluded that there was no difference in onset of sensory blockade but highest level is achieved more rapidly in ketamine group than tramadol group. Haemodynamic stability is better maintained in ketamine group. Duration of analgesia is longer with tramadol than ketamine. References: 1. Jacobson L, Chabal C, Brody MC. A dose-response study of intrathecal morphine: ef cacy, duration, optimal dose, and side effects. Anesth Analg 1988; 67: Vickers MD, O'Flaherty D, Szekely SM, Read M, Yoshizumi J.Tramadol: pain relief by an opioid without depression of respiration. Anaesthesia 1992; 47: Tarkkila P, Tuominen M, Lindgren L. Comparison of respiratory effects of tramadol and pethidine. Eur J Anaesthesiol 1998; 15: Raffa RB, Friderichs E, Reimann W, Shank RP, Codd EE, Vaught JL. Opioid and nonopioid components independently contribute to the mechanism of action of tramadol, an `atypical' opioid analgesic. J Pharmacol Exp Ther 1992; 260: Scott LJ, Perry CM. Tramadol: a review of its use in perioperative pain. Drugs 2000; 60: Tsai YC, Chang PJ, Jou IM. Direct tramadol application on sciatic nerve inhibits spinal somatosensory evoked potentials in rats. Anesth Analg 2001; 92: Wu CL. Acute postoperative pain. 6 th ed. Chapter 72. In: Miller s Anaesthesia. Miller RD, ed. Philadelphia: Elsevier Churchill Livingstone; pp Bamigbade TA, Davidson C, Langford RM, Stamford JA. Actions of tramadol, its enantiomers and principal metabolite, O-desmethyltramadol, on serotonin (5-HT) efflux and uptake in the rat dorsal raphe nucleus. Br J Anaesth 1997; 79: 352±6 9. Baraka A, Jabbour S, Ghabash M, Nader A, Khoury G, Sibai A. A comparison of epidural tramadol and epidural morphine for postoperative analgesia. Can J Anaesth 1993; 40: 308± Siddik-Sayyid S, Aouad-Maroun M, Sleiman D, Sfeir M, Baraka A. Epidural tramadol for postoperative pain after Cesarean section. Can J Anaesth 1999; 46: 731±5 11. Ila Patel, Rachana Ghandhi, Alka Shah comparative study of bupivacaine vs bupivacaine+ketamine (intrathecally) during intraoperative and post operative analgesia in non pih caesarian section, National journal of medical research, Vol 1 Issue 2 Oct - Dec 2011; P Kaliyani Govindan, Rajmani Krishnan, Marc P. Kaufman, et al. Intrathecal ketamine in surgeries for lower abdomen and lower extremities. Proc. West. Pharmacol. Soc 2001; 44: Dipasri Bhattacharya, Arnab Banerjee. Comparative study between intrathecal bupivacaine and intrathecal ketamine. Indian j Anaesth. 2004; 48(2):

9 14. A. Subedi, B.K. Biswas, M. Tripathi et al 14, Analgesic effects of intrathecal tramadol in patients undergoing caesarean section: a randomised, double-blind study, Int J Obstet Anesth (2013), Bion JF: Intrathecal ketamine for war surgery. Anaesthesia 1984; 39(10): Date of submission: 17 September 2013 Date of Provisional acceptance: 28 September 2013 Date of Final acceptance: 27 October 2013 Date of Publication: 04 December 2013 Source of support: Nil; Conflict of Interest: Nil 192