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Completed

NCT Number: NCT06595875

Modified Thoracoabdominal Nerve Block With Perichondrial Approach in Laparoscopic Cholecystectomy Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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