Modified Thoracoabdominal Nerve Block With Perichondrial Approach in Laparoscopic Cholecystectomy Surgery

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Other: m-tapa block

• Registration Number: NCT06595875
• Lead Sponsor: Konya City Hospital

Brief Summary

Our primary objective is to evaluate the postoperative numerical rating scale scores in patients undergoing laparoscopic cholecystectomy with an m-TAPA block. Our secondary objectives are to assess the total amount of rescue analgesia consumed, the time to first rescue analgesia, patient satisfaction, and the occurrence of complications.

Detailed Description

Patients aged 18-65 with American Society of Anesthesiologists physical status I-III, undergoing laparoscopic cholecystectomy under general anesthesia, were included in the study. Patients with contraindications to regional anesthesia, impaired consciousness, coagulopathy, those using anticoagulants, those with infection at the procedure site, those with allergies to local anesthetics, pregnant women, and emergency cases were excluded from the study.

The primary outcome measures were the numerical rating scale pain scores (0-10, 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain) at 0, 2, 4, 8, 12, and 24 hours postoperatively. The secondary outcome measures included the total amount of rescue analgesic consumed, the time to first rescue analgesia, the occurrence of complications (such as infection, hematoma formation, and local anesthetic systemic toxicity), and patient satisfaction. The age, gender, weight, height, surgery duration of patients in both groups were recorded. A Likert scale (1 = not satisfied at all, 2 = not satisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied) was used to assess patient satisfaction.

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10-07
• Primary Completion: 2024-10-21
• Study Completion: 2024-10-21
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18-65 years
• American Society of Anesthesiologists physical status I-III
• Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria

• Patients with contraindications to regional anesthesia
• Impaired consciousness
• Coagulopathy
• Using anticoagulants
• Infection at the procedure site
• Allergies to local anesthetics
• Pregnant women
• Emergency cases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
m-tapa block	m-tapa block	-

Primary Outcome Measures

Name	Time	Method
Postoperative analgesia	24 hours	Our primary objective is to evaluate the postoperative numerical rating scale scores in patients undergoing laparoscopic cholecystectomy with an m-TAPA block. Numerical rating scale score 0-10 point. 0= Very bad, 10= Vey Good.

Trial Locations

Locations (1)

Konya City Hospital; 🇹🇷 Konya, Turkey