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Status:

COMPLETED

Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery

Lead Sponsor:

Claus Anders Bertelsen, PhD, MD

Conditions:

Pain, Postoperative

Pain, Abdominal

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 blo...

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 outco...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

January 14 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2024

Estimated Enrollment :

360 Patients enrolled

Trial Details

Trial ID

NCT04311099

Start Date

January 14 2021

End Date

March 31 2024

Last Update

August 7 2025

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Sydvestjysk Sygehus

Esbjerg, Denmark, 6700

2

Regionshospitalet Herning

Herning, Denmark, 7400

3

Copenhagen University Hospital - North Zealand

Hillerød, Denmark, 3400

4

Copenhagen University Hospital - Hvidovre

Hvidovre, Denmark, 2650