Postoperative Analgesic Efficacy of Modified TAPA and QL Blocks in Laparoscopic Cholecystectomies

July 9, 2025 updated by: SERPİL ŞEHİRLİOĞLU, Gaziosmanpasa Research and Education Hospital

Evaluation of the Postoperative Analgesic Efficacy of Modified Thoracoabdominal Plane Block With Perichondral Approach and Quadratus Lumborum Block in Laparoscopic Cholecystectomies

Comparison of Postoperative Analgesic Effects of M-TAPA and Anterior Quadratus Lumborum Blocks in Laparoscopic Cholecystectomies.

Study Overview

Detailed Description

In trunk blocks, the interfascial area between the anterior abdominal wall or back muscles is targeted. Local anesthetics are used for this purpose. Since there is no blood circulation and vascularization in the interfascial areas, the absorption of local anesthetics is slow, providing long-lasting analgesia. Therefore, they are used as a part of multimodal analgesia. The effectiveness of trunk blocks can vary depending on the patient's anatomical differences and previous surgeries, but on average, analgesic effectiveness lasts for 8-12 hours. Sometimes analgesic effectiveness extending up to 24 hours has been reported.

In laparoscopic cholecystectomy operations, pain plays a role in postoperative atelectasis, pneumonia due to atelectasis, prolonged hospital stay, and discharge. To reduce the use of opioids due to their side effects such as nausea, vomiting, itching, constipation, and addiction, opioid-free analgesia is applied, and regional techniques are used. Quadratus lumborum blocks and M-TAPA blocks have been safely and easily applied in abdominal surgery in recent years thanks to developments in trunk blocks and ultrasound technology, and they are frequently preferred.

Study Type

Interventional

Enrollment (Actual)

108

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

      • Istanbul, Turkey, 34000
        • Gaziosmanpasa Research and Education Hospital

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

Yes

Description

  • Inclusion Criteria:
  • scheduled for elective Laparoscopic chplecystectomy
  • Patients aged ≥18 years
  • American Society of Anesthesiologists physical status (ASA) Ⅰ-II

Exclusion Criteria:

ASA III-IV patient

  • local anesthetic allergy
  • Infection at the procedure site Body Mass Index >35 kg/m2 Anticoagulant use with bleeding disorder Chronic analgesia and opioid use with mental and psychiatric disorders Contraindications to regional anesthesia several lung and heart disease

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quadratus lumborum block group
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.
Active Comparator: m-tapa block
In the M-TAPA block group, with the patient in the supine position, a linear high-frequency linear ultrasound (USG) probe is angled to visualize the inferior surface of the costochondral junction at the level of the 10th costochondral cartilage. Under sterile conditions, using the in-plane technique with a 22G 80 mm peripheral block needle, the needle is advanced posterior to the 10th costal cartilage by taking the lower edge of the cartilage in the sagittal plane as the midline. After hydrodissection with 2-3 ml isotonic saline to confirm the site, 20 ml of 0.25% Bupivacaine is administered under USG guidance. The same procedure is performed on the contralateral side as well.
In the M-TAPA block group, with the patient in the supine position, a linear high-frequency linear ultrasound (USG) probe is angled to visualize the inferior surface of the costochondral junction at the level of the 10th costochondral cartilage. Under sterile conditions, using the in-plane technique with a 22G 80 mm peripheral block needle, the needle is advanced posterior to the 10th costal cartilage by taking the lower edge of the cartilage in the sagittal plane as the midline. After hydrodissection with 2-3 ml isotonic saline to confirm the site, 20 ml of 0.25% Bupivacaine is administered under USG guidance. The same procedure is performed on the contralateral side as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of opioid requirements
Time Frame: within 24 hours after the surgery
The total tramadol use of the patients in 24 hours will be recorded.
within 24 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rescue analgesia
Time Frame: within 24 hours after the surgery
The rescue analgesia requirement and time of the need of the rescue analgesia requirement
within 24 hours after the surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative remifentanil consumption
Time Frame: during operation procedure]
The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.
during operation procedure]
Visual Analogue Scale values
Time Frame: at 1st, 4th,8th 12th and 24th hours after the surgery]
Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
at 1st, 4th,8th 12th and 24th hours after the surgery]
side effects such as nausea, vomiting and shoulder pain
Time Frame: within 24 hours after the surgery
The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.a
within 24 hours after the surgery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Serpil Sehirlioglu, MD, Gaziosmanpasa Research and Education Hospital
  • Study Director: turan aydemir, MD, Gaziosmanpasa Research and Education Hospital
  • Study Director: döndü moralar, MD, Gaziosmanpasa Research and Education Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

May 1, 2024

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 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

product manufactured in and exported from the U.S.

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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