Analgesic Effect of M-TAPA on LC

Not Applicable

Completed

• Conditions: Post Operative Pain
• Interventions: Procedure: modified thoracoabdominal nerve block through perichondrial approach

• Registration Number: NCT05891652
• Lead Sponsor: Cumhuriyet University

Brief Summary

Objective: To investigate the postoperative analgesic efficacy of M-TAPA block and its effect on opioid consumption in patients undergoing laparoscopic cholecystectomy (LC) surgery.

Place and Duration of Study: Department of Anesthesiology and Reanimaton, Sivas Cumhuriyet University, Sivas, Turkey, from April 2023 to May 2023.

Methodology: There were two randomized groups: Group M-TAPA (n=21) and Group Control (no block) (n=21). All patients had standard general anesthesia. Group M-TAPA patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for posteperative pain. Numerical rating scale (NRS) and visual analogue scale (VAS) were used to assess postoperative pain. Total tramadol consumption was calculated.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-11
• Status Verified: 2023-05
• Primary Completion: 2023-05-12
• Study Completion: 2023-05-16
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-26
• Last Update Submitted: 2023-05-26
• Study First Posted: 2023-06-07
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria

• Patients who did not give consent,
• patients with coagulopathy,
• patients with signs of infection at the block application site,
• patients using anticoagulants,
• patients with local anesthetic drug allergies,
• patients undergoing open surgery,
• patients with unstable hemodynamics,
• patients who could not cooperate during postoperative pain assessment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Blocked	modified thoracoabdominal nerve block through perichondrial approach	Patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.

Primary Outcome Measures

Name	Time	Method
numerical rating scale scores	postoperative 24 hours	numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

Secondary Outcome Measures

Name	Time	Method
total tramadol consumption	postoperative 24 hours	postoperative analgesic need

Trial Locations

Locations (1)

Sivas Cumhuriyet University; 🇹🇷 Sivas, Turkey