Comparison of Two Regional Blocks For Pain Treatment After Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Pain, Postoperative

• Registration Number: NCT06768385
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Brief Summary

In laparoscopic cholecystectomies, ultrasound-guided interfascial plane blocks are commonly used for postoperative analgesia. The aim of our study was to compare the postoperative analgesic efficacy of thoracoabdominal nerve block with the perichondral approach (TAPA) with transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy.

Detailed Description

Laparoscopic cholecystectomy (LC) is one of the most frequently performed surgical operations and the postoperative hospital stay is short (1). Although there is less postoperative pain in laparoscopic surgeries than in open surgeries, severe pain is a common complaint, especially in the first 24 hours. Therefore, various modalities have been tried to reduce postoperative pain (2).

In recent years, the effectiveness of ultrasound-guided interfascial plane blocks has come to the fore in the field of regional anaesthesia and pain management. There has always been a search for a regional anaesthesia method that provides effective analgesia of the anterolateral part of the upper abdomen. In addition to anterolateral blocks, such as pectoralis nerve block (PECS) and serratus intercostal plane block (SIBP), other posterior blocks like quadratus lumborum blocks and erector spinus plane blocks have been used for this purpose. TAP block is the application of local anaesthetic agents into the neurofascial space between the internal oblique and transversus abdominis muscle layers located in the anterolateral region of the abdomen. This procedure, in which the anterior branches of the 7th-12th thoracic intercostal and first lumbar (L1) nerves are blocked, is frequently used to provide pain control after operations involving the abdominal and inguinal regions (3,4).

Recently introduced thoracoabdominal nerve blockage with perichondrial approach (TAPA) has been reported to provide sensory blockade between midaxillary line and midabdominal/sternum in dermatomes between T5-T12 (5,6). In TAPA block, local anesthesia is applied to two points, the upper part of the chondrium and the lower part of the chondrium. In this way the anterior and lateral cutaneous branches of the intercostal nerves are blocked. In light of this information, our hypothesis is that the analgesic effect will be greater in TAPA block since the lateral branches of the intercostal nerves are also affected.

The aim of our study is to compare the postoperative analgesic efficacies of TAP and TAPA blocks to be applied to patients undergoing laparoscopic cholecystectomy.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Patients classified as I-II-III by the American Society of Anesthesiologists (ASA) and aged between 20 and 70 years were included in the study

Exclusion Criteria

Patients were excluded if they were younger than 20 years, older than 70 years, had ASA physical status classification IV, were pregnant or had a body mass index (BMI) ≥ 35 kg m-2, had a skin infection at the needle puncture site, had a history of previous abdominal surgery or trauma, were known to be allergic to any of the study drugs, had used any analgesic within 24 hours before surgery, had a history of chronic opioid use, alcohol or drug use, were receiving antithrombotic therapy, and had abnormal coagulation parameters.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
postoperative analgesic efficacy	At the postoperative 2nd, 6th, 12th and 24th hours, the patient's request and administrations from the patient-controlled analgesia (PCA) device, total tramadol dose and the first additional analgesic drug if needed, and application times were recorded.	NRS (Numerical Rating Scale) was used for pain monitoring. Patients were informed about the NRS assessment for pain. It was stated that a score of 0 meant no pain and a score of 10 meant the worst pain imaginable. After the first assessment hour when NRS \>4 was noted in patients, IV analgesia treatment was started (dexketoprofen 50 mg IV as additional analgesic). If NRS \<4 and the patient did not request analgesic, the drug dose was skipped.

Secondary Outcome Measures

Name	Time	Method
presence of nausea-vomiting	the postoperative 2nd, 6th, 12th and 24th hours	presence of nausea-vomiting recorded at the postoperative 2nd, 6th, 12th and 24th hours

Trial Locations

Locations (1)

SBU Sultan Abdulhamid Han; 🇹🇷 Istanbul, Asia, Turkey