- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07403682
M-TAPA vs ESPB for Postoperative Analgesia After Laparoscopic Cholecystectomy
Comparison of M-TAPA and ESPB Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Postoperative pain after laparoscopic cholecystectomy can negatively affect patient comfort, recovery, and opioid consumption. Regional abdominal wall blocks are commonly used as part of multimodal analgesia to improve postoperative pain control and reduce opioid-related side effects.
The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB) are two ultrasound-guided regional anesthesia techniques that have been shown to provide effective postoperative analgesia in abdominal surgery. However, comparative clinical data between these two techniques in laparoscopic cholecystectomy are limited.
This randomized, single-blind clinical trial aims to compare the postoperative analgesic effectiveness of M-TAPA and ESPB in adult patients undergoing elective laparoscopic cholecystectomy. Postoperative pain scores, opioid consumption, time to first analgesic requirement, and patient satisfaction will be evaluated.
Study Overview
Status
Conditions
Detailed Description
This study is designed as a prospective, randomized, single-blind controlled clinical trial conducted in adult patients scheduled for elective laparoscopic cholecystectomy. The primary objective of the study is to compare the postoperative analgesic effectiveness of the modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB).
Eligible patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-II will be randomly assigned in a 1:1 ratio to receive either M-TAPA or ESPB. Randomization will be performed using a computer-generated random number sequence, and allocation will be concealed in sealed, opaque envelopes to prevent selection bias.
All blocks will be performed under ultrasound guidance by experienced anesthesiologists using standard local anesthetic agents routinely applied in clinical practice. The study is designed as single-blind, with patients blinded to group allocation.
Postoperative pain intensity will be assessed using the visual analog scale (VAS) at 0, 1, 6, 12, and 24 hours after surgery. Additional outcome measures include total opioid consumption within the first 24 postoperative hours, time to first analgesic requirement, need for rescue analgesia, and patient satisfaction. Adverse events related to regional anesthesia techniques will be recorded.
The study follows the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval has been obtained from the relevant Clinical Research Ethics Committee prior to study initiation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muzaffer Gencer
- Phone Number: +90 505 9436459
- Email: dr.m.gencer07@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective surgery under general anesthesia
- Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Refusal to participate
- Known allergy to local anesthetics
- Coagulation disorders or anticoagulant therapy
- Infection at the injection site
- Severe hepatic, renal, or cardiac disease
- Chronic opioid use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: M-TAPA Block
An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
|
An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
|
|
Experimental: ESPB
An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
|
An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Opioid Consumption in the First 24 Hours
Time Frame: within the first 24 hours postoperatively
|
Total cumulative opioid consumption within the first 24 hours after surgery, recorded as intravenous tramadol equivalent dose.
|
within the first 24 hours postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCS-MTAPA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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