NCT06058715

TAP Block Versus Conventional Systemic Analgesia

TAP Block Versus Conventional Systemic Analgesia in Laparoscopic Surgery: A Prospective Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Ministry of Scientific Research, Tunisia · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Analgesia

Interventions

Type	Name	Description
PROCEDURE	Transverse Abdominal Plan block (TAP block)	Bilateral TAP block is administered intraoperatively at laparoscopy, directly after insufflation and insertion of the first trocar and camera. The ultrasound probe is placed longitudinally on the midaxillary line near umbilicus, and the transversus abdominis and internal oblique muscles are scanned and observed. The needle (22-gauge 90 mm disposable spinal needle) is inserted in plane and after placing the needle-tip into the fascia between transversus abdominis and internal oblique muscles, 20 ml of ropivacaine 0.25% is injected bilaterally. It is all done by one Anesthetist which is expert in that area and is not in charge of collecting the data.

Timeline

• Start date: 2023-09-15
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-09-28
• Last updated: 2023-09-28

Locations

1 site across 1 country: Tunisia