Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pneumoperitoneum
- Sponsor
- University of Jordan
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- assessment of pain with SPS-11 at 6hr post-op
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to assess the effect of low-pressure pneumoperitoneum on post operative pain and inflammation in patients undergoing elective laparoscopic cholecystectomy by comparing it to standard practice.
Detailed Description
After obtaining informed consent from eligible study participants. patients were randomized into one of two masked groups, labelled red and green. The red-label group was operated at standard-pressure pneumoperitoneum, while the green-label group was operated at low-pressure pneumoperitoneum. Baseline blood samples were obtained pre-operatively for ten inflammatory markers, patients' demographics and intra-operative details collected, then post-operative pain and change in inflammatory markers were followed.
Investigators
Hanan Ibrahim Mansour
Dr. Hanan Mansour, M.D.
University of Jordan
Eligibility Criteria
Inclusion Criteria
- •Elective admission for laparoscopic cholecystectomy
Exclusion Criteria
- •Current or previous diagnosis of acute cholecystitis confirmed by ultrasound
- •previous GI surgeries, except bariatric and anti-reflux surgeries
- •Currently on immunosuppressant agents
- •Pregnancy
- •Breastfeeding
- •Currently diagnosed with drug addiction
- •American Society of Anesthesiologists (ASA) score 3 and more
Outcomes
Primary Outcomes
assessment of pain with SPS-11 at 6hr post-op
Time Frame: pre-op to 6 hours post op
measure difference in pain on the 11-point short pain scale (SPS-11) at 6-hour post-op compared to baseline at pre-op, minimum score of 0 , maximun score of 10 = pain at 6 hour post op - pain at pre-op
change in IL-6
Time Frame: pre op to 24 hours post -op
measure differance of inflammatory marker from baseline = baseline value- post op value (calculated in pg/mL) post-op collected at 24 hours from end of surgery
Secondary Outcomes
- assessment of difficulty of surgery(start to end of the study, 1 year)
- assessment of difference in operation time(start to end of the study, 1 year)