M-TAPA vs Intraperitoneal Bupivacain vs Intraperitoneal Bupivacain +Dexmedetomidin

NCT06482229 | Completed

• 1 other identifier: m-tapa vs intraperiton
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

• pain scores

  zero meaning "no pain" and 10 meaning "the worst pain imaginable

  Time Frame: 24 hours after the procedure

Secondary Outcomes (1)

• total analgesic consumption

  24 hours after the procedure

Study Arms (3)

m-tapa

EXPERIMENTAL

Procedure: application for postoperative analgesia

intraperitoneal bupivacain

EXPERIMENTAL

Procedure: application for postoperative analgesia

intraperitoneal bupivacain+dexmedetomidin

EXPERIMENTAL

Procedure: application for postoperative analgesia

Interventions

application for postoperative analgesia PROCEDURE

three different methods will be applied to reduce patients' postoperative pain

intraperitoneal bupivacain; intraperitoneal bupivacain+dexmedetomidin; m-tapa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sivas State Hospital: lead

Study Sites (1)

Fatih Balci

Sivas, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist/Department of Anaesthesiology and Reanimation

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: July 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)