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M-TAPA vs Intraperitoneal Bupivacain vs Intraperitoneal Bupivacain +Dexmedetomidin

S

Sivas State Hospital

Status

Completed

Conditions

Regional Anesthesia Morbidity

Treatments

Procedure: application for postoperative analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT06482229
m-tapa vs intraperiton

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

51 participants in 3 patient groups

m-tapa
Experimental group
Treatment:
Procedure: application for postoperative analgesia
intraperitoneal bupivacain
Experimental group
Treatment:
Procedure: application for postoperative analgesia
intraperitoneal bupivacain+dexmedetomidin
Experimental group
Treatment:
Procedure: application for postoperative analgesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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