M-TAPA vs Intraperitoneal Bupivacain vs Intraperitoneal Bupivacain +Dexmedetomidin

Not Applicable

Completed

• Conditions: Regional Anesthesia Morbidity
• Interventions: Procedure: application for postoperative analgesia

• Registration Number: NCT06482229
• Lead Sponsor: Sivas State Hospital

Brief Summary

Laparoscopic cholecystectomy is a common abdominal surgery in Western countries, favored for its minimal invasiveness, leading to less pain, smaller scars, and quicker recovery. Despite its benefits, it is contraindicated in cases of bleeding disorders, peritonitis, hemodynamic instability, severe heart failure, and advanced COPD. Effective postoperative pain management is crucial for faster recovery, shorter hospital stays, and lower costs, using techniques such as intravenous or intramuscular analgesics, epidural analgesia, and local anesthetic injections like TAP block or M-TAPA block. The TAPA block, introduced in 2019, involves applying local anesthetic to the costochondral junction, affecting thoracoabdominal nerves, with a modified version (M- TAPA) applying anesthetic to the lower surface only. Studies have shown M-TAPA's efficacy in reducing pain and analgesic use postoperatively. Postoperative pain from laparoscopic cholecystectomy mainly arises from inflammation in the gallbladder bed and pneumoperitoneum. This study aims to evaluate the postoperative analgesic efficacy of intraperitoneal bupivacaine, bupivacaine with dexmedetomidine, and M-TAPA block by assessing pain scores and analgesic consumption in a prospective, randomized, double- blind trial with 45 patients. Patients will be assigned to three groups: M- TAPA block, intraperitoneal bupivacaine, and intraperitoneal bupivacaine with dexmedetomidine, with an experienced anesthetist administering the blocks and evaluating outcomes to compare these pain management techniques.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Study Start: 2024-07-01
• Study First Posted: 2024-07-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Laparoscopic cholecystectomy surgery planned
• ASA #-II-III classification
• Willingness to participate in the study

Exclusion Criteria

• Bleeding disorders
• Signs of infection at the block application site
• Conversion to open surgery
• Allergy to local anesthetics
• Unstable hemodynamics
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
intraperitoneal bupivacain	application for postoperative analgesia	-
m-tapa	application for postoperative analgesia	-
intraperitoneal bupivacain+dexmedetomidin	application for postoperative analgesia	-

Primary Outcome Measures

Name	Time	Method
pain scores	Time Frame: 24 hours after the procedure	zero meaning "no pain" and 10 meaning "the worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
total analgesic consumption	24 hours after the procedure	total rescue analgesic consumption of patients will be evaluated

Trial Locations

Locations (1)

Fatih Balci; 🇹🇷 Sivas, Turkey