- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07483190
Effectiveness of Thoracoabdominal Nerve Block (M-TAPA) on Postoperative Pain Relief in Laparoscopic Hysterectomy
Effectiveness of Modified-Thoracoabdominal Nerve Block With Perichondrial Approach (M-TAPA) on Postoperative Pain Relief in Laparoscopic Hysterectomy Surgery: A Prospective, Randomized, Double-Blind, Controlled Study
This study aims to investigate the effectiveness of a specific regional anesthesia technique, the Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA), on reducing pain after laparoscopic hysterectomy surgery. Hysterectomy is a common major surgical procedure, and managing postoperative pain is crucial for patient comfort and faster recovery.
Participants will be randomly assigned to one of two groups:
The M-TAPA Group: Patients will receive the nerve block using a local anesthetic (bupivacaine) before the surgery begins.
The Control Group: Patients will receive standard postoperative pain management without the nerve block.
The primary goal is to determine if the M-TAPA block reduces the total amount of opioid (morphine) used by patients in the first 24 hours after surgery. The researchers will also evaluate pain scores (NRS), the time until the first request for additional pain medication, patient satisfaction, and any side effects like nausea or vomiting
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: onur senyurt
- Phone Number: +905520265992
- Email: senyurtonur@yahoo.com
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Istinye University Liv Hospital Bahcesehir
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Contact:
- onur senyurt
- Phone Number: +905520265992
- Email: senyurtonur@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18 and 70 years
- ASA (American Society of Anesthesiologists) physical status I, II, or III
- Scheduled for elective laparoscopic hysterectomy
- Voluntary participation with signed informed consent
Exclusion Criteria:
- Hepatic or renal disease.
- Coagulation disorders.
- Uncontrolled cardiovascular or respiratory diseases.
- Psychiatric disorders.
- History of allergy to local anesthetics.
- History of alcoholism, drug or substance abuse.
- Body Mass Index (BMI) greater than 35 kg/m2
- Refusal of the regional block procedure
Study Plan
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 |
|---|---|
|
No Intervention: Control Group
|
|
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Experimental: M-TAPA Group
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Under ultrasound guidance, a 22-gauge peripheral block needle is inserted at the costochondral angle (9th-10th ribs).
After confirming the position, 20 ml of 0.25% bupivacaine is injected bilaterally into the lower part of the chondrium.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morphine consumption
Time Frame: First 24 hours postoperatively
|
Total amount of morphine (mg) used via Patient-Controlled Analgesia (PCA)
|
First 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Scores (NRS)
Time Frame: Baseline (Hour 0), 1, 2, 4, 6, 12, and 24 hours postoperatively
|
Numerical Rating Scale (0=no pain, 10=worst pain)
|
Baseline (Hour 0), 1, 2, 4, 6, 12, and 24 hours postoperatively
|
|
Rescue analgesic drug consumption
Time Frame: Within the first 24 hours postoperatively
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The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.
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Within the first 24 hours postoperatively
|
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Incidence of postoperative nausea and vomiting
Time Frame: Within the first 24 hours postoperatively
|
Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours
|
Within the first 24 hours postoperatively
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- anestezi tapa
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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