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Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery

NCT04311099 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Claus Anders Bertelsen, PhD, MD

    lead OTHER

Principal Investigators

  • Claus A Bertelsen, PhD · Copenhagen University Hospital - North Zealand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-14
Primary Completion
2024-02-08
Completion
2024-03-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311099 on ClinicalTrials.gov