Clinical trial NCT06058715: TAP Block Versus Conventional Systemic Analgesia
Official title: TAP Block Versus Conventional Systemic Analgesia in Laparoscopic Surgery: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: Ministry of Scientific Research, Tunisia
Sponsor class: OTHER_GOV
First posted: 2023-09-28
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%

Primary outcomes:
measure: Opioid consumption during the first 48 h postoperatively.
timeFrame: Every six hours
Secondary outcomes:
measure: Pain intensity on a numerical rating scale (pain NRS, 0-10)
timeFrame: Every six hours
measure: Postoperative evaluation at 4 weeks
timeFrame: At 4 weeks after surgery
Other outcomes:
Locations:
city: Ariana
country: Tunisia
facility: Department of surgery, Mahmoud El Matri hospital, Ariana, Tunisia
Study officials:
References: