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Clinical Trials/NCT06482229
NCT06482229
Completed
Not Applicable

Postoperative Analgesic Efficacy of Intraperitoneal Bupivacaine, Bupivacaine and Dexmedetomidine With Modified-Pericondrial Approach Thoracoabdominal Nerve Block (M-TAPA) in Laparoscopic Cholecystectomy Surgeries

Sivas State Hospital1 site in 1 country51 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Regional Anesthesia Morbidity
Sponsor
Sivas State Hospital
Enrollment
51
Locations
1
Primary Endpoint
pain scores
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
September 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Sivas State Hospital
Responsible Party
Principal Investigator
Principal Investigator

Fatih Balcı

Specialist/Department of Anaesthesiology and Reanimation

Sivas State Hospital

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

Outcomes

Primary Outcomes

pain scores

Time Frame: Time Frame: 24 hours after the procedure

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

Secondary Outcomes

  • total analgesic consumption(24 hours after the procedure)

Study Sites (1)

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