Modified Thoracoabdominal Nerve Block With Perichondrial Approach in Laparoscopic Cholecystectomy Surgery

NCT06595875 | Completed

• 1 other identifier: m-tapa
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative analgesia

  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.

  24 hours

Study Arms (2)

control group

NO INTERVENTION

m-tapa block

ACTIVE COMPARATOR

Other: m-tapa block

Interventions

m-tapa block OTHER

Patients in Group M were placed in the supine position. After skin antisepsis with 5% povidone-iodine, a sterile drape was placed. The high-frequency (8-13 MHz) linear ultrasound (USG) probe was covered with a sterile sheath, and the transversus abdominis, internal oblique, and external oblique muscles were identified at the 10th costal margin in the sagittal plane at the costochondral angle. The probe was angled sagittally to visualize the costochondral angle at the edge of the 10th rib and to display the posterior surface of the rib cartilage in the midline. Using an in-plane technique, a 22-gauge, 100-millimeter (mm) Stimuplex A peripheral nerve block needle was advanced cranially, and the needle tip was directed towards the posterior surface of the 10th costal cartilage. After negative aspiration, 20 mL of 0.25% bupivacaine was injected under the lower surface of the costal cartilage. The same procedure was repeated on the opposite side.

m-tapa block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist, the member of the Department of Anesthesiology, Konya City Hospital, M.D

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 7, 2024
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)