NCT04311099

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Claus Anders Bertelsen, PhD, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pain, Postoperative
• Pain, Abdominal
• Analgesia
• Surgery
• Colon Cancer
• Injection Site

Interventions

Type	Name	Description
DRUG	Active drug	Injection of Ropivacaine
DRUG	Placebo	Injection of Saline solution
PROCEDURE	Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block	Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
PROCEDURE	Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block	Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
PROCEDURE	Injection of placebo - Ultrasound-guided transverse abdominal plane block	Lateral ultrasound-guided transverse abdominal plane block with saline solution
PROCEDURE	Injection of placebo - Laparoscopic assisted transverse abdominal plane block	Laparoscopic assisted subcostal transverse abdominal plane block with saline solution

Timeline

• Start date: 2021-01-14
• Primary completion: 2024-02-08
• Completion: 2024-03-31
• First posted: 2020-03-17
• Last updated: 2025-08-07

Locations

5 sites across 1 country: Denmark