Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery

Summary

The purpose of the trial is to identify the "most simple non-inferior of three different methods", placebo, laparoscopic assisted transverse abdominal plane block (L-TAP) and ultrasound guided TAP block (US-TAP), using postoperative opioid consumption as a measure of efficacy in patients undergoing elective minimally invasive colon surgery in an ERAS setting. Postoperative pain scores and length of stay (LOS) will also be measured. The simplicity of the three methods is ranked as: 1) placebo, 2) L-TAP and 3) US-TAP.

Timeline

Start

2021-01-14

Primary completion

2024-02-08

Completion

2024-03-31

Outcome

Mixed primary results

paper The US-TAP block was no different from placebo at -1.4 mg morphine (97.5% CI -6.8 to 4.0 mg; p=0.55). PMID 39542642 ↗

paper The L-TAP block was superior to placebo at -5.9 mg morphine (97.5% CI -11.3 to -0.5 mg; p=0.01) PMID 39542642 ↗

Publications

• Background Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25.
• Background Grant MC, Yang D, Wu CL, Makary MA, Wick EC. Impact of Enhanced Recovery After Surgery and Fast Track Surgery Pathways on Healthcare-associated Infections: Results From a Systematic Review and Meta-analysis. Ann Surg. 2017 Jan;265(1):68-79. doi: 10.1097/SLA.0000000000001703.
• Background Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
• Background Neal JM, Brull R, Chan VW, Grant SA, Horn JL, Liu SS, McCartney CJ, Narouze SN, Perlas A, Salinas FV, Sites BD, Tsui BC. The ASRA evidence-based medicine assessment of ultrasound-guided regional anesthesia and pain medicine: Executive summary. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S1-9. doi: 10.1097/AAP.0b013e3181d22fe0.
• Background Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.
• Background Keller DS, Madhoun N, Ponte-Moreno OI, Ibarra S, Haas EM. Transversus abdominis plane blocks: pilot of feasibility and the learning curve. J Surg Res. 2016 Jul;204(1):101-8. doi: 10.1016/j.jss.2016.04.012. Epub 2016 Apr 27.
• Background Keller DS, Ermlich BO, Schiltz N, Champagne BJ, Reynolds HL Jr, Stein SL, Delaney CP. The effect of transversus abdominis plane blocks on postoperative pain in laparoscopic colorectal surgery: a prospective, randomized, double-blind trial. Dis Colon Rectum. 2014 Nov;57(11):1290-7. doi: 10.1097/DCR.0000000000000211.
• Background Favuzza J, Brady K, Delaney CP. Transversus abdominis plane blocks and enhanced recovery pathways: making the 23-h hospital stay a realistic goal after laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2481-6. doi: 10.1007/s00464-012-2761-y. Epub 2013 Jan 26.
• Background Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
• Background Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
• Background Chetwood A, Agrawal S, Hrouda D, Doyle P. Laparoscopic assisted transversus abdominis plane block: a novel insertion technique during laparoscopic nephrectomy. Anaesthesia. 2011 Apr;66(4):317-8. doi: 10.1111/j.1365-2044.2011.06664.x. No abstract available.
• Background Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ. Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):335-44. doi: 10.1016/j.jamcollsurg.2015.03.030. Epub 2015 Mar 27.
• Background Park SY, Park JS, Choi GS, Kim HJ, Moon S, Yeo J. Comparison of Analgesic Efficacy of Laparoscope-Assisted and Ultrasound-Guided Transversus Abdominis Plane Block after Laparoscopic Colorectal Operation: A Randomized, Single-Blind, Non-Inferiority Trial. J Am Coll Surg. 2017 Sep;225(3):403-410. doi: 10.1016/j.jamcollsurg.2017.05.017. Epub 2017 Jun 10.
• Background Zaghiyan KN, Mendelson BJ, Eng MR, Ovsepyan G, Mirocha JM, Fleshner P. Randomized Clinical Trial Comparing Laparoscopic Versus Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colorectal Surgery. Dis Colon Rectum. 2019 Feb;62(2):203-210. doi: 10.1097/DCR.0000000000001292.
• Background Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
• Background Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
• Background Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
• Background Dickerson DM, Apfelbaum JL. Local anesthetic systemic toxicity. Aesthet Surg J. 2014 Sep;34(7):1111-9. doi: 10.1177/1090820X14543102. Epub 2014 Jul 15.
• Background Naidu RK, Richebe P. Probable local anesthetic systemic toxicity in a postpartum patient with acute Fatty liver of pregnancy after a transversus abdominis plane block. A A Case Rep. 2013 Dec 1;1(5):72-4. doi: 10.1097/ACC.0b013e3182973a2f.
• Background Statzer N, Cummings KC 3rd. Transversus Abdominis Plane Blocks. Adv Anesth. 2018 Dec;36(1):163-180. doi: 10.1016/j.aan.2018.07.007. Epub 2018 Sep 27. No abstract available.
• Background Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545.
• Background Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess 1995; 7: 524.
• Results Lund H, Spanager L, Winther ACR, Gierloff M, Sunekaer K, Kleif J, Bertelsen CA. Recurrence and complications after laparoscopic inguinal hernia repair using a self-adherent mesh: a patient-reported follow-up study. Surg Endosc. 2025 Apr;39(4):2464-2470. doi: 10.1007/s00464-025-11614-7. Epub 2025 Feb 24.
• Results Salmonsen CB, Lange KHW, Kleif J, Kroijer R, Bruun L, Mikalonis M, Dalsgaard P, Hesseldal KB, Olsson JEP, Bertelsen CA; OPMICS Study Group. Transversus abdominis plane block in minimally invasive colon surgery: a multicenter three-arm randomized controlled superiority and non-inferiority clinical trial. Reg Anesth Pain Med. 2026 May 5;51(5):558-567. doi: 10.1136/rapm-2024-105712.
• Salmonsen CB, Lange KHW, Kleif J, Bertelsen CA. Optimal peripheral nerve block after minimally invasive colon surgery - a study protocol for a randomised trial. Dan Med J. 2021 Nov 12;68(12):A03210245.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ropivacaine	Other / unclassified	2 mg/ml	Other

Indications