EUCTR2020-001054-22-DK
Active, not recruiting
Phase 1
aparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colon Surgery: A Randomized Controlled Multicentre Clinical Trial - OPMICS
Claus Anders Bertelsen0 sites360 target enrollmentMarch 25, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Claus Anders Bertelsen
- Enrollment
- 360
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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