Clinical trial NCT06768385: Comparison of Two Regional Blocks For Pain Treatment After Laparoscopic Cholecystectomy
Official title: Comparison of The Efficacy of TAP and TAPA (Thoracoabdominal Nerve Blockage With Perichondrial Approach) Blocks For Pain Treatment After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: laparoscopic cholecystectomy
transversus abdominis plane block
thoracoabdominal nerve block with the perichondral approach
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomly allocated to one of two groups using a computer-generated randomized sequence table with an allocation ratio of 1:1 and a block size of two.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: postoperative analgesic efficacy
timeFrame: 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.
Secondary outcomes:
measure: presence of nausea-vomiting
timeFrame: the postoperative 2nd, 6th, 12th and 24th hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SBU Sultan Abdulhamid Han
state: Asia
Study officials:
affiliation: Sultan Abdülhamid Han education and research hospital
name: Dilek M Yamac
role: PRINCIPAL_INVESTIGATOR
References: