Optimal Peripheral nerve block after Minimally Invasive Colon Surgery

Phase 1

• Conditions: Colon cancer patients undergoing elective minimally invasive colon surgery and receiving a transversus abdominis plane block for postoperative pain management. Ropivacaine is used as the local analgetic injected and a saline solution is used as the placebo.; MedDRA version: 21.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-001054-22-DK
• Lead Sponsor: Claus Anders Bertelsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-25
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

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.
-Age = 18 years
-Having given informed written consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210

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)19
-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified