- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06995404
- Original Trial
Transversus Abdominis Plane Block (TAP) Versus Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Laparoscopic Gynecologic Surgeries
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ELA ERDEM HIDIROGLU
- Phone Number: 03127970000
- Email: drelaerdem@gmail.com
Study Locations
-
-
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Ankara, Turkey, 06010
- Ankara Etlik City Hospital
-
Contact:
- ela erdem hıdıroglu
- Phone Number: +905348874184
- Email: drelaerdem@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Female patients aged between 18 and 80 years, classified as ASA physical status I to III, undergoing laparoscopic gynecologic surgery under general anesthesia -
Exclusion Criteria:Coagulopathy
Neuropathy
Chronic analgesic therapy
Severe cardiopulmonary disease
Uncontrolled diabetes mellitus (HbA1c > 8%)
Severe renal or hepatic failure
Pregnancy or lactation
Body mass index (BMI) greater than 35 kg/m²
Local infection at the injection site
Inability to comprehend pain scores or cooperate (e.g., Alzheimer's disease, mental retardation)
Allergy to local anesthetic agents
Refusal to participate in the study
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
|
|
|
Active Comparator: group TAP
|
Patients in the TAP group will receive a bilateral Transversus Abdominis Plane (TAP) block under ultrasound guidance prior to surgery after general anaesthesia, with the local anesthetic administered between the internal oblique and transversus abdominis muscles.
A total of 40 mL of 0.25% bupivacaine will be used for the procedure.
|
|
Active Comparator: group M-TAPA
|
Patients in the M-TAPA group will receive a bilateral Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) under ultrasound guidance prior to surgery after general anaesthesia.
A total of 40 mL of 0.25% bupivacaine will be used for the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluation of intraoperative opioid consumption
Time Frame: during surgery
|
during surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of postoperative Visual Analog Scale (VAS) pain scores
Time Frame: postoperative first day
|
VAS is an eleven-scale pain score scored from 0 to 10, with vas 0 being no pain and vas 10 being maximum pain.
|
postoperative first day
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- AESH-EK-2025-028
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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