TAP Block Versus Conventional Systemic Analgesia in Laparoscopic Surgery: A Prospective Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Analgesia
- Sponsor
- Ministry of Scientific Research, Tunisia
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- Opioid consumption during the first 48 h postoperatively.
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.
Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.
Detailed Description
Laparoscopic cholecystectomy constitutes a routinely performed procedure world-wide. Analgesia accounts for one of the major keys for success especially in enhanced recovery after surgery pathway and ambulatory surgery. Hence, controlling opioid consumption used in conventional systemic analgesia is mandatory while reliving pain. The TAP block is integrated within a multimodal analgesia. It corresponds to a locoregional analgesia. The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant. Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.
Investigators
Sana Landolsi
Associate professor in general surgery, University Tunis El Manar, Faculty of medicine of Tunis, Department of surgery, Mahmoud El Matri hospital, Ariana, Tunisia
Ministry of Scientific Research, Tunisia
Eligibility Criteria
Inclusion Criteria
- •All patients scheduled for elective laparoscopic cholecystectomy at the department of surgery, Mahmoud El Matri Hospital, Ariana
Exclusion Criteria
- •Severe renal insufficiency (GFR \< 30 ml/min)
- •Severe hepatic insufficiency (TT ≤ 50%)
- •Severe COPD (FEV1 \> 30%)
- •Metastatic malignancy
- •Hematologic disease or a congenital clotting disorder
- •Preoperative opioid use
- •Age under 18 years
- •Pregnancy or breast-feeding
- •Hyper-reactivity toward ropivacaine
- •Estimated risk for conversion to open surgery \> 50%
Outcomes
Primary Outcomes
Opioid consumption during the first 48 h postoperatively.
Time Frame: Every six hours
Opioids are given only on request based on pain numerical rating scale (pain NRS) varying from 0 to10. For pain NRS \> 3 at rest or for pain NRS \> 5 on exercise, oxycodone is administrated intravenously at the recovery room at the dose of 0.05 mg/kg. Then, it is used intramuscularly at the dose of 0.1 mg/kg up to 24 hours after surgery and orally at the dose of 0.15 mg/kg between 24 and 48 hours after surgery. At 2 to 4 weeks postoperatively, all patients are contacted either by phone or at the outpatient clinic during a follow-up visit and asked to complete a form with questions evaluating pain sensations, pain intensity, need for pain medication, performance of daily activities, and any limitations of these due to postoperative abdominal pain.
Secondary Outcomes
- Pain intensity on a numerical rating scale (pain NRS, 0-10)(Every six hours)
- Postoperative evaluation at 4 weeks(At 4 weeks after surgery)