Analgesic Effect of M-TAPA and TAPB on Laparoscopic Cholesistectomy

Not Applicable

Recruiting

• Conditions: Post Operative Pain

• Registration Number: NCT06662617
• Lead Sponsor: Cumhuriyet University

Brief Summary

Cholecystectomy is the most frequently performed abdominal surgery in developed nations, with laparoscopic cholecystectomy being recognized as the gold standard technique for treating gallstones.

The efficacy of TAP block for pain relief has been well-documented following laparoscopic cholecystectomy procedures. Recently, m-TAPA block has emerged as an alternative analgesic technique for abdominal surgeries.

This study aims to evaluate and compare the effectiveness of these two analgesic methods in managing postoperative pain after laparoscopic cholecystectomy.

Detailed Description

Cholecystectomy is the most commonly performed abdominal surgery in developed countries, with laparoscopic cholecystectomy regarded as the gold standard technique for gallstone treatment.

Postoperative pain following laparoscopic cholecystectomy is influenced by several factors, making it a complex and predominantly visceral pain. These factors include phrenic nerve irritation due to CO2 insufflation, abdominal distension, port site incisions, the effects of gallbladder removal, and individual patient characteristics.

Regional analgesia has gained widespread acceptance from both patients and physicians, becoming a key component of multimodal analgesia techniques. The transversus abdominis plane (TAP) block has proven effective in reducing postoperative pain in surgeries such as hysterectomy, cholecystectomy, cesarean section, and colorectal procedures.

The Ultrasound (US)-guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) involves administering a local anesthetic to the underside of the perichondral surface. This technique provides effective analgesia for the anterior and lateral thoracoabdominal regions.

The purpose of this study is to compare the efficacy of US-guided M-TAPA block with TAP block for postoperative analgesia following cholecystectomy.

Study Timeline

• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-26
• Study First Posted: 2024-10-29
• Status Verified: 2024-11
• Study Start: 2024-11-01
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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: PARALLEL

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)

Medicana Sivas Hospital; 🇹🇷 Sivas, Turkey