Modified Thoracoabdominal Nerve Block With Perichondrial Approach in Laparoscopic Cholecystectomy Surgery

NCT ID: NCT06595875

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-07
• Study Completion Date: 2024-10-21

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.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

m-tapa block

Group Type: ACTIVE_COMPARATOR

m-tapa block

Intervention Type: 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.

Interventions

m-tapa block

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Muhammed Halit Satici

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Konya City Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

m-tapa

Identifier Type: -

Identifier Source: org_study_id