Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery (NCT04311099) | Clinical Trial Compass
CompletedPhase 4
Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery
Denmark360 participantsStarted 2021-01-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total morphine dose equivalents administered.
Timeframe: The first 24 hours from the end of anesthesia.