TAP Block Versus Conventional Systemic Analgesia

Not Applicable

Active, not recruiting

• Conditions: Analgesia

• Registration Number: NCT06058715
• Lead Sponsor: Ministry of Scientific Research, Tunisia

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.

Study Timeline

• Study First Submitted: 2023-06-08
• Status Verified: 2023-09
• Study Start: 2023-09-15
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 380

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Opioid consumption during the first 48 h postoperatively.	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 Outcome Measures

Name	Time	Method
Pain intensity on a numerical rating scale (pain NRS, 0-10)	Every six hours	pain intensity is measured 30 min after arrival and then every hour until the patient is discharged to the ward. In the ward, the pain NRS score is measured for each consecutive 6-h block. Means of the first and second 6-h blocks and third and fourth blocks are calculated and used for further analysis. Additionally, the maximal daily pain NRS scores are collected. At the time of discharge, patients evaluate their satisfaction with pain management as a whole (scale 0-3: 0 poor; 3 excellent).
Postoperative evaluation at 4 weeks	At 4 weeks after surgery	At 4 weeks postoperatively, all patients are contacted either by phone 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.

Trial Locations

Locations (1)

Department of surgery, Mahmoud El Matri hospital, Ariana, Tunisia; 🇹🇳 Ariana, Tunisia