BIER ' S BLOCK USING DIFFERENT DOSES OF PARACETAMOL ADDED TO LIDOCAINE IN PATIENTS UNDERGOING HAND SURGERIES.

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1 AAMJ, Vol. 10, N. 3, Sep, 2012, Suppl-3 BIER ' S BLOCK USING DIFFERENT DOSES OF PARACETAMOL ADDED TO LIDOCAINE IN PATIENTS UNDERGOING HAND SURGERIES. Reda K. Abdel-Rahman*, Montaser S. Ahmed**, Mahmoud G. Montaser*, Abdelbadee A. Ahmed* and Ibrahim E. Elalfy* Faculty of Medicine of Al-Azhar University*, Menoufia University**. ABSTRACT Background: This study was done to evaluate the effects of different doses of paracetamol when added to lidocaine for intravenous regional anesthesia (IVRA). Methods: seventy five patients undergoing hand surgery received IVRA were assigned to three groups (n = 25 each): Group I: received lidocaine (3 mg/kg) diluted with normal saline and paracetamol 100 mg to a volume of 40 ml. Group II: receive dlidocaine(3 mg/kg) diluted with normal saline and paracetamol 200 mg to a total volume of 40 ml and Group III: received lidocaine (3 mg/kg) diluted with normal saline and paracetamol 300 mg to a total volume of 40 ml. Measurements: sensory and motor block onset and recovery time, the visual analog scale (VAS) scores of tourniquet pain at 30 min till 12 h postoperatively, the time to first analgesic requirement, total analgesic consumption and side effects. Results: Sensory and motor block onset of Group II and III were significantly shorter than group I(p<0.0001, p<0.001 respectively). Durations of Sensory and motor block in Group II and III were significantly longer than group I(p<0.003,p<0.04 respectively). After one hour postoperatively till 12 h, VAS was significantly higher in group I which required fentanyl analgesia. The time of first dose of fentanyl was significantly longer in Group II and III (p< 0.05) than Group I. Fentanyl requirement in Group II and III are significantly lower than Group I (p<0.05). Conclusion: Paracetamol as 181

2 Haitham A. Azeem et al an adjunct to lidocaine improves analgesia quality of IVRA without adverse effects. Keywards: paracetamol, lidocaine, intravenous regional anesthesia (IVRA), VAS, fentanyl. Corresponding Author: REDA KHALIL ABDELRAHMAN, MD Lecturerof Anesthesia, Faculty of Medicine, AL- AzharUniversity. Mailing address: Egypt,Kalioubia,Toukh,Kafer Alfokhaa. Mobile: INTRODUCTION Intravenous regional anesthesia (IVRA) is described firstly in 1908 by August Bier. It is simple, safe, reliable, less cost, efficient method in hand surgery. The advantage of this method has fast return of motor and sensory function which enables patients for earlier discharge (1, 2). However, this method has disadvantages such as tourniquet pain, insufficient muscle relaxation and postoperative analgesia (3).In order to avoid these disadvantages, many adjuvant drugs have been added to local anesthetics (4-8). Many adjuvant drugs in literature, such as, NSAIDs (5), paracetamol (6), opioids (9) and adrenergic receptor agonists (10). Paracetamol has central nervous system effect and peripheral antinociceptive properties in different pain models. Paracetomol was introduced as an infusion in clinical practice in Various paracetamol studies have demonstrated successful improvements in analgesia when added to lidocaine in IVRA. There are no clinical studies in the literature comparing the efficacy of least dose of paracetamol when added to lidocaine in IVRA. The current study evaluated the effect of different doses of paracetamol solution when added to lidocaine in IVRA for elective hand surgeries. METHODS This prospective, double blinded, randomized study that was done on 75 ASA physical status I II patients, after approval of local ethics committee of Al-Azhar University with informed written consent from all patients. They were 182

3 AAMJ, Vol. 10, N. 3, Sep, 2012, Suppl-3 scheduled for hand surgery with exclusion of Patients with Reynaud's disease, sickle cell anemia, and a history of allergy to any used drug. Patients were randomized in equal numbers by research assistant who used a computergenerated permuted block randomization schedule to three groups with 25 patients each. Identical syringes containing each drug were prepared by an anesthesia assistant not involved in the study. Patients were premedicated with IV 0.03 mg/kg of midazolam. In the operating room, patients were monitored for mean arterial blood pressure (MAP), oxygen saturation (Spo2), and heart rate (HR). Two cannulas were placed; one was in a vein on the dorsum of the operative hand and the other in the opposite hand for crystalloid maintenance infusion. The operative arm was elevated for 2 min and was then exsanguinated with an Esmarch bandage. A pneumatic double tourniquet (Tourniquet 2800 ELC, UMB Medizin-tecknick GmbH, Germany) was then placed around the upper arm, and the proximal cuff was inflated to 100 mm Hg above the systolic pressure of the patient. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index finger. IVRA was achieved with 3 mg/kg of lidocaine plus 100 mg paracetamol (Perfalgan 10 mg/ml, Bristol-Myers Squibb) diluted with saline to a total of 40 ml in Group I (n = 25), 3 mg/kg of lidocaine plus 200 mg of paracetamol diluted with saline to a total of 40 ml in GroupII (n = 25), and 3 mg/kg of lidocaine plus 300 mg paracetamol diluted with saline to a total of 40 ml in Group III (n = 25). The solutions were prepared and injected over 90 s by an anesthesiologist not involved in the study. After injection, sensory block onset(the time elapsed from injection of study drug to sensory block) was evaluated with pinprick testing every 30 s. motor block onset (the time elapsed from injection of study drug to complete motor block) was assessed by asking the patient to flex and extend his wrist and 183

4 Haitham A. Azeem et al fingers; complete motor block was noted when no voluntary movement was possible. After complete sensory and motor blocks were achieved, the distal tourniquet was inflated to 100 mm Hg above the systolic pressure of the patient, the proximal tourniquet was released, and surgery was started. Hemodynamic monitoring were recorded before and after the application of the tourniquet and during the operation (5, 10, 15, 20, 30, 40, and 50 min) and after release of the tourniquet by the blinded observing anesthesiologist. Pain due to the tourniquet was assessed and recorded with a 10-cm visual analog scale (VAS) before and after the application of the tourniquet and during the operation (5, 10, 15, 20, 30, 40, and 50 min).if the patient reported VAS >4, 1 μg/kg of fentanyl was given. At the end of the operation, the Patient satisfaction was graded as follows: (4) excellent, (3) good, (2) moderate, (1) poor(11). At the end of surgery, the tourniquet was deflated by cyclic deflation technique. Sensory recovery time was noted (time elapsed after tourniquet deflation up to recovery of pain in all innervated areas determined by pinprick test done every 30 s). Motor block recovery time was noted (the time elapsed after tourniquet deflation up to movement of fingers). First analgesic requirement time was also noted (the time elapsed after tourniquet release to first patient request of analgesic). Patients were assessed by one of the authors for 12 hours in the postsurgical ward for hemodynamics, VAS, and sedation 1, 2, 4, 6and 12hours postoperatively. Any expected side effects or complications were detected and recorded such as bradycardia, hypotension, drug allergy and skin rashes. 184

5 AAMJ, Vol. 10, N. 3, Sep, 2012, Suppl-3 Power analysis: A power analysis was performed using a power of 90% and α value We assumed that paracetamol was expected to produce a change in block characters in group II & III 40 % more than in group I with a standard deviation 20%.The sample size was calculated to be 23 patients so we decided to include 25 patients in each group in the study. Graph padin stat statistics version 3 programs was used for power analysis. Statistical data analysis was carried out by using Statistical Package for Social Sciences (SPSS) for Windows Release 19.0 program. Mann-Whitney - test was used for comparison of qualitative data. Variance analysis (ANOVA test) and Chi-Square was used for comparison of repetitive quantitative measurements which continue from the beginning. Data obtained through measurements were expressed as mean, standard deviation and data obtained by count was expressed as %. Significance level was accepted if P value <0.05. RESULTS No difference was detected between the groups in terms of age, gender, ASA, surgery durations, satisfaction score, types of surgery and tourniquet periods (Table 1, 2). Sedation score was significantly lesser In Group I in comparison to Group II and Group III (P<0.0001). (Table, 1). No statistical significant difference was found between the groups in terms of intraoperative and postoperative HR, MAP and SpO 2 values. (figure1, 2). Sensory and motor block onset of Group II and III were significantly shorter than group I (p<0.0001, p<0.001 respectively). Durations of Sensory and motor block in Group II and III were significantly longer than group I (p<0.003, p<0.04 respectively).there was no statistically significant difference 185

6 Haitham A. Azeem et al between Groups II and III in terms of sensorial and motor block onset and duration periods. (Table3 &Figure3) VAS values of Group II and III were similar to group I except one hour postoperatively till 12 h, VAS was statistically significant increased in group I which required fentanyl analgesia (Table4). There was no significant difference in VAS values between Group II and Group III all over the study period (Table4). The time of first dose of fentanyl was significantly lesser in Group I in comparison to Group II and group III. Also, the amount of fentanyl required in patients of Group I was significantly higher than patients of Group II and group III (p<0.0001,table3). Table1: Demographic data, duration of surgery, tourniquet time, satisfaction and sedation score of the studied groups. Group I Group II Group III Fvalue/chi (n=25) (n=25) (n=25) Square test P value Age (years) 52.5± ± ± Sex (Female 8/17(47%) 9/16(56%) 10/15 (66%) /Male) Weight (Kg) 78.5± ± ± >0.05 ASA Status (I/II) 19/6 18/7 20/5 Duration of surgery 39.24± ± ± Satisfaction score 2.32± ± ± Sedation score 1.6± ± ± < Tourniquet time (min.) 48.64± ± ±

7 AAMJ, Vol. 10, N. 3, Sep, 2012, Suppl-3 Table2: Types of surgery in the three studied groups. Group I (n=25) Group II (n=25) Group III (n=25) Carpal tunnel release Ganglion excision Trigger finger Cyst excision

8 Haitham A. Azeem et al Table3: Block characteristics, fentanyl use in the three studied groups. Onset of sensory block (seconds) Onset of motor block (min.) First analgesia time (min.) Recovery of sensory block after tourniquet deflation Recovery of motor block after tourniquet deflation Amount of fentanyl used (micrograms) Group I (n=25) Group II (n=25) Group III (n=25) F value/chi Square test P value 387± ± ± < ± ± ± < ± ± ± ± ± ± < ± ± ± < ± ± ± <

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10 Haitham A. Azeem et al Table4: Intraoperative and postoperative Pain Scores (VAS) in the three studied groups. GROUP I GROUPII GROUPIII F P VALUE Before tourniquet 3.2± ± ± After tourniquet inflation 5 0.6±1 0.6±1 0.4± min. 10 min. 0.4± ± ± min. 1.7± ± ± min. 1.4±2 1.0± ± min. 1.8±2 1.2± ± min. 2.04± ± ± min. 0.6±2 0.4±2 0.34± hour 5.35± ± ± < hours 4.47± ± ± < hours 4.32± ± ± < hours 4.35± ± ± hours 4.96± ± ± DISCUSSION Different studies had been done on the effect of adjuvant drugs added to IVRA. different types of drugs were used as sufentanil (12), tramadol (13)(14)(15), dexamethasone, lornoxicam, most of these different adjuvants reduced patient anxiety, sympatho-adrenal responses, and opioid analgesic requirements but they did not reduce tourniquet pain.(16,17,18) It is surprising that after more than 100 years, the exact mechanism of action of paracetamol remains to be determined. There is evidence for a number of central mechanisms, including effects on prostaglandin production, on serotonergic, opioid, nitric oxide and cannabinoid pathways. It is likely that combinations of interrelated pathways are in fact involved. (19, 20) 190

11 AAMJ, Vol. 10, N. 3, Sep, 2012, Suppl-3 In the present study, adding paracetamol to lidocaine in dose of 200mg or 300mg as compared to 100mg dose was shown to improve the overall quality of the block. Onset of sensory and motor block was sooner, tourniquet pain was reduced and recovery of motor and sensory block was delayed, resulting in lower intraoperative pain scores and total systemic analgesic requirements. Fahim et al postulated that paracetamol s actions are centrally mediated; an analgesic benefit conferred from its addition to a peripherally sequestered pool of drug is a surprising finding. (12) Ko et al. added 300 mg of intravenous paracetamol into 0.5% lidocainea in IVRA. They reported a shorter sensorial block onset time in paracetamol group, intraoperativeanalgesia requirement was less, and intraoperative and postoperative VAS values were lower. But there was no difference in terms of sensorial block return times. (21) In another study conducted by Celik et al. who added 200 mg of paracetamol to lidocaine (3 mg/kg), they reported that there was no difference between sensorial and motor block onset and return times; furthermore, requirement of intraoperative analgesia was less. (22). Sen et al. did not find any difference between sensorial and motor block onset time between the group where paracetamol (300 mg) was added and the control group. But, They reported that postoperative sensorial block return time was longer in the paracetamol group and intraoperative analgesia requirement was less.(23) In the present study there were no significant differences in the hemodynamics and no adverse effects occurred in all patients. No adverse events were detected in the study conducted by Ko et al. (21). But, Sen et al. (23) reported nausea in three patients in their study. 191

12 Haitham A. Azeem et al This is the first clinical study comparing the addition of different doses of Paracetamol to lidocaine for IVRA. Superiority of one over the other could not be established as 300mg and 200mg produced the same block characters. 200mg or 300 mg Paracetamol was associated with better patient satisfaction than 100mg dose. Contrasting to the findings of this study was the study of Ali Akdogan and Ahmet Eroglu, who found that the addition of paracetamol and dexketoprofen to the lidocaine in upper limb regional intravenous anesthesia does not create any significant difference.(24) Also, Alireza Mirkheshti et al. postulated that the enhancement effect on IVRA is most prominent in patients receiving magnesium plus lidocaine, but not so much seen after adding paracetamol to lidocaine. (25) CONCLUSION Selection as well as dosing of Paracetamol as an adjuvant to lidocaine clearly improves the IVRA block characteristics. RECOMMENDATIONS According to the results obtained in the current study, paracetamol 200 mg can be used sufficiently as an adjuvant to lidocaine during IVRA and no need for the increaseddose to300mg. ACKNOWLEDGEMENT We thank Dr Ayat Abd El-Rahman and Dr. Hassam Negm (University of Alexandria) for their statistical support and invaluable help in the preparation of the final manuscript. Conflict of Interests The authors declare that there is no conflict of interests regarding the publication of this paper. 192

13 AAMJ, Vol. 10, N. 3, Sep, 2012, Suppl-3 REFERENCES 1. Candido KD, Winnie AP - Intravenous regional block for upper and lower extremity surgery In HadzicA (Ed.). Textbook of Regional Anesthesia and Acute Pain Management, 2. Ed, NewYork, McGraw-Hill Profesional 2007; Brill S, Middleton W, Brill G et al. - Bier's block: 100 years old and still going strong. ActaAnaesthesiolScand, 2004;48: Brown EM, McGriff JT, Malinowski RW- Intravenous regional anesthesia: review of 20 years experience. Can J Anaesth, 1989;36: Sıngh R, Bhagwat A, Bhadoria P et al. - Forearm IVRA using 0.5% lidocaine in a dose 1.5 mg/kg with ketorolac 0.15 mg/kg for hand and wrist surgeries. Minerva Anestesiol, 2010;76: Jones NC, Pugh SC - The addition of tenoxicam to prilocaine for intravenous regional anaesthesia. Anaesthesia, 1996;51: Sen H, Kulahci Y, Bicerer E et al. - The analgesic effect of paracetamol when added to lidocaine for intravenous regional anesthesia. Anethesia Analgesia, 2009;109: Sen S, Ugur B, Aydın ON et al. - The analgesic effect of lornoxicam when added to lidocaine for intravenous regional anesthesia. British J Anesthesia, 2006;97: Viscomi CM, Friend A, Parker C et al. - Ketamine as an adjuvant in lidocaine intravenous regional anesthesia: A randomized, double-blind, systemic control trial. RegAnesth Pain Med, 2009;34:

14 Haitham A. Azeem et al 9. Aslan B, Izdes S, Kesimci E et al. - Comparison of the effects of lidocaine, lidocaine plus tramadol, and lidocaine plus morphine for intravenous regional anesthesia. Agri, 2009;21: Memis D, Turan A, Karamanlıoglu B et al. - Adding dexmedetomidine to lidocaine for intravenous regional anesthesia. AnesthAnalg, 2004;98: Turan A, Karamanlýoglu B, Memis D, Kaya G, Pamukçu Z. Intravenous regional anesthesia using prilocaine and neostigmine. AnesthAnalg 2002;95: M. R. Fahim, H. M. B. Eldeen, and W. Saad, The addition of sufentanil, tramadol or dexmedetomidine to lidocaine for intravenous regional anaesthesia, Egyptian Journal of Anaesthesia, vol. 21, no. 4, pp , I. Acalovschi, T. Cristea, S. Margarit, and R. Gavrus, Tramadol added to lidocaine for intravenous regional anesthesia, Anesthesia and Analgesia, vol. 92, no. 1, pp , S. M. Tan, L. L. Pay, and S. T. Chan, Intravenous regional anaesthesia using lignocaine and tramadol, Annals of the Academy of Medicine Singapore, vol. 30, no. 5, pp , S. Özcan, H. Üstün, and F. N. Baran, Lidocaine and tramadol hydrochloride in intravenous regional anaesthesia, IMRA, vol. 11, pp , Z. Bigat and N. Boztuğ, Riva'dalidokainvelidokain'eeklenentenoksikamvedeksametazonunkarşılaştır ılması, TürkAnesteziyolojiveReanimasyonDerneğiDergisi, vol. 32, pp ,

15 AAMJ, Vol. 10, N. 3, Sep, 2012, Suppl-3 17.S. Sen, B. Ugur, O. N. Aydin, M. Ogurlu, E. Gezer, and O. Savk, The analgesic effect of lornoxicam when added to lidocaine for intravenous regional anaesthesia, The British Journal of Anaesthesia, vol. 97, no. 3, pp , M. Celik, F. Saricaoglu, O. Canbay et al., WITHDRAWN the analgesic effect of paracetamol when added to lidocaine for intravenous regional anesthesia, Minerva Anestesiologica. In press. 19.Mattia C,,Coluzzi F.What anesthesiologists should know about paracetamol (acetaminophen). Minerva Anestesiol 2009;75: Smith H. Potential analgesic mechanism of acetaminophen. Pain Physician2009;12: Sen H, Kulahci Y, Bicerer E, Ozkan S, Dagli G,Turan A.The analgesic effect of paracetamol when added to lidocaine for intravenous regional anesthesia. AnesthAnalg 2009;109: M. J. Ko, J. H. Lee, S. H. Cheong et al., Comparison of the effects of acetaminophen to ketorolac when added to lidocaine for intravenous regional anesthesia, Korean Journal of Anesthesiology, vol. 58, no. 4, pp , S. Yurtlu, V. Hanci, E. Kargi et al., The analgesic effect of dexketoprofen when added to lidocaine for intravenous regional anaesthesia: a prospective, randomized, placebo-controlled study, International Journal of Medical Research, vol. 39, no. 5, pp , H. Sen, Y. Kulahci, E. Bicerer, S. Ozkan, G. Dagl, and A. Turan, The analgesic effect of paracetamol when added to lidocaine for intravenous 195

16 Haitham A. Azeem et al regional anesthesia, Anesthesia and Analgesia, vol. 109, no. 4, pp , BioMed Research International.Volume 2014 (2014), Article ID , 5 pages. 25.Alireza Mirkheshti, Mohammad Reza Aryani, PoujiaShojaei, and Ali Dabbagh.TheEffect of Adding Magnesium Sulfate to Lidocaine Compared with Paracetamol in Prevention of Acute Pain in Hand Surgery Patients Under Intravenous Regional Anesthesia (IVRA).Int J Prev Med 2012 Sep;3(9):