Skip to main content
Clinical Trials/NCT06595875
NCT06595875
Completed
N/A

Modified Thoracoabdominal Nerve Block With Perichondrial Approach in Laparoscopic Cholecystectomy Surgery: A Prospective, Randomized, Controlled, Double-Blind Study

Konya City Hospital1 site in 1 country60 target enrollmentOctober 7, 2024
ConditionsAnalgesia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Analgesia
Sponsor
Konya City Hospital
Enrollment
60
Locations
1
Primary Endpoint
Postoperative analgesia
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2024
End Date
October 21, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Konya City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Muhammed Halit Satici

Specialist, the member of the Department of Anesthesiology, Konya City Hospital, M.D

Konya City Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postoperative analgesia

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials