Assessing the feasibility of a randomised, double-blinded, placebo-controlled trial to investigate the role of intraperitoneal ropivacaine in gastric bypass surgery: a protocol

Robert Wu, Fatima Haggar, N'Gai Porte, Naveen Eipe, Isabelle Raiche, Amy Neville, Jean Denis Yelle, Tim Ramsay, Joseph Mamazza, Robert Wu, Fatima Haggar, N'Gai Porte, Naveen Eipe, Isabelle Raiche, Amy Neville, Jean Denis Yelle, Tim Ramsay, Joseph Mamazza

Abstract

Introduction: Postoperative pain control remains a major challenge for surgical procedures, including laparoscopic gastric bypass. Pain management is particularly relevant in obese patients who experience a higher number of cardiovascular and pulmonary events. Effective pain management may reduce their risk of serious postoperative complication, such as deep vein thrombosis and pulmonary emboli. The objective of this study is to evaluate the efficacy of intraperitoneal local anaesthetic, ropivacaine, to reduce postoperative pain in patients undergoing laparoscopic Roux-en-Y gastric bypass.

Methods and analysis: A randomised controlled trial will be conducted to compare intraperitoneal ropivacaine (intervention) versus normal saline (placebo) in 120 adult patients undergoing bariatric bypass surgery. Ropivacaine will be infused over the oesophageal hiatus and throughout the abdomen. Patients in the control arm will undergo the same treatment with normal saline. The primary end point will be postoperative pain at 1, 2 and 4 h postoperatively. Pain measurements will then occur every 4 h for 24 h and every 8 h until discharge. Secondary end points will include opioid use, peak expiratory flow, 6 min walk distance and quality of life assessed in the immediate postoperative period. Intention-to-treat analysis will be used and repeated measures will be analysed using mixed modelling approach. Post-hoc pairwise comparison of the treatment groups at different time points will be carried out using multiple comparisons with adjustment to the type 1 error. Results of the study will inform the feasibility of recruitment and inform sample size of a larger definitive randomised trial to evaluate the effectiveness of intraperitoneal ropivacaine.

Ethics and dissemination: This study has been approved by the Ottawa Health Science Network Research Ethics Board and Health Canada in April 2014. The findings of the study will be disseminated through national and international conferences and peer-reviewed journals.

Trial registration number: Clinicaltrial.gov NCT02154763.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
CONSORT flow diagram of the INOPAIN study. Source: Moher et al (IPLA, intraperitoneal local anaesthetic).

References

    1. Fernandez AZ, Demaria EJ, Tichansky DS, et al. Multivariate analysis of risk factors for death following gastric bypass for treatment of morbid obesity. Ann Surg 2004;239:698–703
    1. Narchi P, Benhamou D, Fernandez H. Intraperitoneal local anaesthetic for shoulder pain after day-case laparoscopy. Lancet 1991;338:1569–70
    1. Bisgaard T, Klarskov B, Kristiansen VB, et al. Multi-regional local anesthetic infiltration during laparoscopic cholecystectomy in patients receiving prophylactic multi-modal analgesia: a randomized, double-blinded, placebo-controlled study. Anesth Analg 1999;89: 1017–24
    1. El-Sherbiny W, Saber W, Askalany AN, et al. Effect of intra-abdominal instillation of lidocaine during minor laparoscopic procedures. Int J Gynaecol Obstet 2009;106:213–15
    1. Kang H, Kim B-G. Intraperitoneal ropivacaine for effective pain relief after laparoscopic appendectomy: a prospective, randomized, double-blind, placebo-controlled study. J Int Med Res 38:821–32
    1. Kahokehr A, Sammour T, Shoshtari KZ, et al. Intraperitoneal local anesthetic improves recovery after colon resection: a double-blinded randomized controlled trial. Ann Surg 2011;254:28–38
    1. Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg 2006;103:682–8
    1. Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol 2012;19:545–53
    1. Pappas-Gogos G, Tsimogiannis KE, Zikos N, et al. Preincisional and intraperitoneal ropivacaine plus normal saline infusion for postoperative pain relief after laparoscopic cholecystectomy: a randomized double-blind controlled trial. Surg Endosc 2008;22:2036–45
    1. Gupta A. Local anaesthesia for pain relief after laparoscopic cholecystectomy—a systematic review. Best Pract Res Clin Anaesthesiol 2005;19:275–92
    1. Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence. Anesthesiology 2006;104:835–46
    1. Graf BM. The cardiotoxicity of local anesthetics: the place of ropivacaine. Curr Top Med Chem 2001;1:207–14
    1. Knudsen K, Beckman Suurküla M, Blomberg S, et al. Central nervous and cardiovascular effects of i.v. infusions of ropivacaine, bupivacaine and placebo in volunteers. Br J Anaesth 1997;78:507–14
    1. Callesen T, Hjort D, Mogensen T, et al. Combined field block and i.p. instillation of ropivacaine for pain management after laparoscopic sterilization. Br J Anaesth 1999;82:586–90
    1. Labaille T, Mazoit JX, Paqueron X, et al. The clinical efficacy and pharmacokinetics of intraperitoneal ropivacaine for laparoscopic cholecystectomy. Anesth Analg 2002;94:100–5
    1. Kucuk C, Kadiogullari N, Canoler O, et al. A placebo-controlled comparison of bupivacaine and ropivacaine instillation for preventing postoperative pain after laparoscopic cholecystectomy. Surg Today 2007;37:396–400
    1. Park YH, Kang H, Woo YC, et al. The effect of intraperitoneal ropivacaine on pain after laparoscopic colectomy: a prospective randomized controlled trial. J Surg Res 2011;171:94–100
    1. Cha SM, Kang H, Baek CW, et al. Peritrocal and intraperitoneal ropivacaine for laparoscopic cholecystectomy: a prospective, randomized, double-blind controlled trial. J Surg Res 2012;175:251–8
    1. Symons JL, Kemmeter PR, Davis AT, et al. A double-blinded, prospective randomized controlled trial of intraperitoneal bupivacaine in laparoscopic Roux-en-Y gastric bypass. J Am Coll Surg 2007;204:392–8
    1. Alkhamesi NA, Kane JM, Guske PJ, et al. Intraperitoneal aerosolization of bupivacaine is a safe and effective method in controlling postoperative pain in laparoscopic Roux-en-Y gastric bypass. J Pain Res 2008;1:9–13
    1. Sherwinter DA, Ghaznavi AM, Spinner D, et al. Continuous infusion of intraperitoneal bupivacaine after laparoscopic surgery: a randomized controlled trial. Obes Surg 2008;18:1581–6
    1. Rodriguez L. Intraperitoneal analgesia compared with levobupivacaine 0.25% versus saline in laparoscopic bariatric surgery: 14AP5-11. Eur J Anaesthesiol 2011;28:203
    1. Betton D, Greib N, Schlotterbeck H, et al. The pharmacokinetics of ropivacaine after intraperitoneal administration: instillation versus nebulization. Anesth Analg 2010;111:1140–5
    1. Maestroni U, Sortini D, Devito C, et al. A new method of preemptive analgesia in laparoscopic cholecystectomy. Surg Endosc 2002;16:1336–40
    1. Gallagher EJ, Bijur PE, Latimer C, et al. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med 2002;20:287–90
    1. Larsson UE, Reynisdottir S. The six-minute walk test in outpatients with obesity: reproducibility and known group validity. Physiother Res Int 2008;13:84–93
    1. Myles PS, Weitkamp B, Jones K, et al. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth 2000;84:11–15
    1. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002;166:111–17
    1. Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285:1987–91

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner