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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.
Introducing laparoscopy in colorectal surgery and optimizing the postoperative care using the standardized protocols of enhanced recovery after surgery (ERAS) have significantly improved patient outcomes and LOS. Better pain management has the potential to further improve these outcomes. Since the introduction of ultrasound-guided abdominal wall blocks, much research has been done in that field, but no consensus has been reached concerning the optimal block technique; where to and when to inject the block, or which drug to use. Newly published randomized controlled trials show interesting results regarding the L-TAP which has several advantages to the US-TAP, including the ease of performance, less dependency on specialized skills or equipment and avoidance of intraperitoneal infiltration. but these results need to be solidified with multicentre trials. Besides optimizing postoperative pain management, better block techniques could potentially decrease LOS in patients after minimally invasive colorectal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-guided TAP | Experimental | Ultrasound-guided TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and laparoscopic assisted injection of 20 ml saline (placebo) bilaterally at the beginning of surgery |
|
| Laparoscopic assisted TAP | Experimental | Laparoscopic assisted TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery |
|
| Placebo | Placebo Comparator | Laparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active drug | Drug | Injection of Ropivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine dose equivalents administered. | Intravenously in milligrams. | The first 24 hours from the end of anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine dose equivalents administered in the operation theater. | Intravenously in milligrams. | Up to 12 hours. |
| Total morphine dose equivalents administered in the post anesthesia care unit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus A Bertelsen, PhD | Copenhagen University Hospital - North Zealand | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydvestjysk Sygehus | Esbjerg | 6700 | Denmark | |||
| Regionshospitalet Herning |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28742427 | 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. | |
| 28009729 | Background |
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After de-identification, individual participant data will be made available to investigators who provide a methodologically sound proposal for meta-analyses. Proposals should be directed to Claus A Bertelsen (cabertelsen@gmail.com). A Data Processing Agreement according to the EU General Data Protection Regulation has to be signed before data sharing.
For 15 years after publication
A methodologically sound proposal for meta-analyses
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| Placebo | Drug | Injection of Saline solution |
|
|
| Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block | Procedure | Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml |
|
| Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block | Procedure | Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml |
|
| Injection of placebo - Ultrasound-guided transverse abdominal plane block | Procedure | Lateral ultrasound-guided transverse abdominal plane block with saline solution |
|
| Injection of placebo - Laparoscopic assisted transverse abdominal plane block | Procedure | Laparoscopic assisted subcostal transverse abdominal plane block with saline solution |
|
Intravenously in milligrams.
| The first 24 hours from the end of anesthesia. |
| Postoperative pain at rest - 8:00-10:00 AM (ante meridiem) Postoperative Day 1. | 11-point Numeric Rating Scale. 0-10 (higher score - worse outcome). | Postoperative Day 1. |
| Postoperative pain when coughing - 8:00-10:00 AM Postoperative Day 1 | 11-point Numeric Rating Scale. 0-10 (higher score means worse outcome) | Postoperative Day 1. |
| Postoperative length of stay. | Days - Measured from the end of anesthesia. | Up to 30 days. |
| Incidence of Postoperative Nausea and Vomiting - 8:00-10:00 AM Postoperative Day 1. | 4-point Numeric Rating Scale. 0-3 (higher score means worse outcome). | Postoperative Day 1. |
| Total dose of antiemetic medication administered. | Intravenously in milligrams. | In the first 24 hours from the end of anesthesia. |
| Total dose of antiemetic medication administered in the operating theater. | Intravenously in milligrams. | Up to 12 hours. |
| Time spent in the post anesthesia care unit. | From the end of anesthesia to discharge to ward. Measured in hours and minutes. | Up to 30 hours. |
| Postoperative mobilisation. | 4-point Verbal Rating Scale. 1-4 (higher score means worse outcome). | Postoperative Day 1. |
| Quality of Recovery 15. | The Quality of Recovery 15 is a 15-item questionnaire that measures the patient's quality of recovery. Each item is answered on an 11-point Numerical Rating Scale. The score ranges from 0 to 150 with a higher score indicating a better quality of recovery. It measures in the domains of pain, physical comfort, physical independence, psychological support, and emotional state. | Postoperative Day 1. |
| Postoperative complications. | According to the Clavien-Dindo classification of surgical complications. | Postoperative Day 30. |
| Need for rescue TAP-block or epidural analgesia. | Epidural or TAP-block administered post surgery. | Postoperative Day 30. |
| Herning |
| 7400 |
| Denmark |
| Copenhagen University Hospital - North Zealand | Hillerød | 3400 | Denmark |
| Copenhagen University Hospital - Hvidovre | Hvidovre | 2650 | Denmark |
| Regionshospitalet Viborg | Viborg | 8800 | Denmark |
| 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. |
| 22632762 | 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. |
| 20216019 | 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. |
| 27429253 | 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. |
| 27451874 | 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. |
| 25285696 | 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. |
| 23355160 | 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. |
| 11576144 | 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. |
| 18020088 | 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. |
| 21401554 | 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. |
| 25899736 | 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. |
| 28610880 | 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. |
| 30540660 | 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. |
| 23411725 | 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. |
| 15273542 | 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. |
| 6880820 | 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. |
| 25028740 | 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. |
| 25612087 | 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. |
| 30414636 | 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. |
| 28085788 | 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. |
| 39994048 | Result | 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. |
| 39542642 | Result | 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. |
| 34851250 | Derived | 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. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D015746 | Abdominal Pain |
| D000377 | Agnosia |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000095485 | Bulk Drugs |
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
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