Comparison of Two Regional Blocks For Pain Treatment After Laparoscopic Cholecystectomy

Comparison of The Efficacy of TAP and TAPA (Thoracoabdominal Nerve Blockage With Perichondrial Approach) 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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Asia
      • Istanbul, Asia, Turkey, 34668
        • SBU Sultan Abdulhamid Han

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group T
After general anesthesia induction, TAP block was applied to Group T. TAP block is the application of local anaesthetic agents to the neurofascial space between the internal oblique and transversus abdominis muscle layers located in the anterolateral region of the abdomen.
: 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.
Active Comparator: group P
TAPA block was applied to Group P. In TAPA block, local anesthesia is applied to two points, the upper part of the chondrium and the lower part of the chondrium.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
the postoperative 2nd, 6th, 12th and 24th hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dilek M Yamac, Sultan Abdülhamid Han education and research hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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