NCT04311099CompletedPhase 4
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 360 (actual)
- First submitted
- 9 Mar 2020
- Start date
- 14 Jan 2021
- Primary completion date
- 8 Feb 2024
- Lead sponsor
- Claus Anders Bertelsen, PhD, MD
- Diseases
- Colorectal cancer
- NCT number
- NCT04311099
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 360
- From 14 Jan 2021 to the primary completion date, 8 Feb 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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 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
Other illness
- Known allergy to local analgesics
- Known liver failure Class C according to the Child-Pugh Score
- History of being a chronic pain patient (weekly intake WHO step II or step III or adjuvant step I analgesic)
- Predictably non-compliant due to language barrier or psychiatric disease
- Patients with known inflammatory bowel disease
- 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
Other
- Body weight of less than 40 kg
- Incisional hernia
- Pregnancy (patients are screened using urine human chorionic gonadotropin upon admission if female and not postmenopausal).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sydvestjysk Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Unknown status |
| Regionshospitalet Herning Coordinator of this site? Confirm its status | Herning | Denmark | Unknown status |
| Copenhagen University Hospital - North Zealand Coordinator of this site? Confirm its status | Hillerød | Denmark | Unknown status |
| Copenhagen University Hospital - Hvidovre Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
| Regionshospitalet Viborg Coordinator of this site? Confirm its status | Viborg | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.