EUCTR2020-001054-22-DKActive, not recruitingPhase 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 enrollmentStarted: March 25, 2020Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 360
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
Similar Trials
Not yet recruiting
Not Applicable
aparoscopic Assisted versus Ultrasound Guided Transversus Abdominis Plane Block in Laparoscopic Bariatric Surgery: A Randomized Controlled TrialPACTR202206871825386Department of Surgery Ain shams university120
Completed
Not Applicable
Comparison between two methods of pain relief after Hernia surgery in children.CTRI/2017/04/008341Mahatma Gandhi Memorial Government Hospital60
Completed
Phase 3
A clinical trial to compare the effectiveness of three regional blocks for post-operative pain in children undergoing inguinal hernia repairCTRI/2019/09/021377All India Institute of Medical SciencesBhubaneswar
Not yet recruiting
Unknown
Comparison of ultrasound guided abdominal blocks for postoperative pain relief in adults undergoing elective lower abdominal surgeryCTRI/2023/07/055201DEPARTMENT OF ANAESTHESIA
Completed
Not Applicable
A study to compare the post operative analgesia and ease of performance following the surgical repair of inguinal hernias and orchidopexy in childreACTRN12608000575336Dr Michael Fredrickson100