M-TAPA vs Intraperitoneal Bupivacain vs Intraperitoneal Bupivacain +Dexmedetomidin

NCT ID: NCT06482229

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

m-tapa

Group Type: EXPERIMENTAL

application for postoperative analgesia

Intervention Type: PROCEDURE

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

intraperitoneal bupivacain

Group Type: EXPERIMENTAL

application for postoperative analgesia

Intervention Type: PROCEDURE

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

intraperitoneal bupivacain+dexmedetomidin

Group Type: EXPERIMENTAL

application for postoperative analgesia

Intervention Type: PROCEDURE

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

Interventions

application for postoperative analgesia

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sivas State Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fatih Balcı

Specialist/Department of Anaesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fatih Balci

Sivas, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

m-tapa vs intraperiton

Identifier Type: -

Identifier Source: org_study_id