Clinical trial · Interventional
Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery
Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colon Surgery: A Randomized Controlled Multicentre Clinical Trial
NCT04311099CI-TRIAL-00093272OPMICScompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesia | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Injection Site | — | UNRESOLVED | — |
| Pain, Abdominal | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active drug | Drug | — | UNRESOLVED |
| Injection of placebo - Laparoscopic assisted transverse abdominal plane block | Procedure | — | UNRESOLVED |
| Injection of placebo - Ultrasound-guided transverse abdominal plane block | Procedure | — | UNRESOLVED |
| Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block | Procedure | — | UNRESOLVED |
| Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block | Procedure | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Ultrasound-guided TAP
- description
- 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
- interventionNames
- Drug: Active drug
- Drug: Placebo
- Procedure: Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block
- Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block
- type
- EXPERIMENTAL
- label
- Laparoscopic assisted TAP
- description
- 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
- interventionNames
- Drug: Active drug
- Drug: Placebo
- Procedure: Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients planned to receive curative elective minimally invasive colon surgery for colon cancer or adenoma without a planned ostomy. Colon cancer or adenoma is defined by a distance of more than 15 cm from the anal verge to the distal limitation of the tumour or adenoma as measured by rigid sigmoidoscope. The following procedural codes are included: * Laparoscopic ileocecal resection * Laparoscopic right hemicolectomy * Other laparoscopic resection of both small and large bowel * Laparoscopic resection of transverse colon * Laparoscopic left hemicolectomy * Laparoscopic resection of sigmoid colon * Other laparoscopic colon resection * Having given informed written consent. Exclusion Criteria: * Known allergy to local analgesics * Known liver failure Class C according to the Child-Pugh Score * Body weight of less than 40 kg * History of being a chronic pain patient (weekly intake WHO step II or step III or adjuvant step I analgesic) * Presence of concomitant painful conditions other than low back pain that could confound the subject's trial assessments or self-evaluation of the index pain, e.g., syndromes with widespread pain such as fibromyalgia * Predictably non-compliant due to language barrier or psychiatric disease * Patients rescheduled for open surgery, before the intervention has been administered * Patients where the indication for surgery changes before the intervention has been administered * Patients with known inflammatory bowel disease * Patients who have previously undergone open major abdominal surgery defined by prior intraabdominal surgery with a midline or upper abdominal incision of more than 8 cm * Incisional hernia * Patients with a history of abdominal wall surgery including resection of the external oblique muscles, the internal oblique muscles, the transversus abdominis muscles, the rectus abdominis muscles or their fascial components * Pregnancy (patients are screened using urine human chorionic gonadotropin upon admission if female and not postmenopausal).
References
Publications (25)
- BACKGROUNDHelander 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. PMID 28742427
- BACKGROUNDGrant 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. PMID 28009729
- BACKGROUNDJohns 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. PMID 22632762
- BACKGROUNDNeal 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. PMID 20216019
- BACKGROUNDBorglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378. PMID 27429253
- BACKGROUNDKeller 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. PMID 27451874
- BACKGROUNDKeller 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.