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Completed

NCT Number: NCT06768385

Comparison of Two Regional Blocks For Pain Treatment After Laparoscopic Cholecystectomy

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBU Sultan Abdulhamid Han

Istanbul, Asia, 34668, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Transversus abdominis plane (TAP) block

Procedure

: It was performed under USG guidance using 30 ml of 0.25% bupivacaine with an 80 mm insulated peripheral block needle. Local anaesthetic was applied between the upper fascia of the transversus abdominus muscle and the fascia of the internal oblique muscle at the midpoint of the distance between the costal margin and the iliac crest in the midaxillary line under USG imaging guidance.

thoracoabdominal nerve blockage with perichondrial approach (TAPA) block

Procedure

Under USG guidance, 20 ml of 0.25% bupivacaine was administered between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue at the level of the 9th and 10th ribs (arcus costarum) in the midclavicular line with an 80 mm insulated peripheral block needle. Then, 10 ml of 0.25% bupivacaine was injected into the upper fascia of the costochondral tissue and the lower fascia of the external oblique muscle. The block was performed by following the needle path in the ultrasound image.

Primary outcomes

  1. postoperative analgesic efficacy

    Time frame: 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 outcomes

  1. presence of nausea-vomiting

    Time frame: the postoperative 2nd, 6th, 12th and 24th hours

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

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

Comparison of The Efficacy of TAP and TAPA (Thoracoabdominal Nerve Blockage With Perichondrial Approach) Blocks For Pain Treatment After Laparoscopic Cholecystectomy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

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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