Intertransverse Process Block Versus M-TAPA Block After Laparoscopic Hysterectomy
Intertransverse Process Block Versus M-TAPA Block After Laparoscopic Hysterectomy: A Prospective Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Beste Mutlu Dağlıoğlu
- Phone Number: +905546892608
- Email: drbeste.bm@gmail.com
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective laparoscopic hysterectomy
- Body mass index (BMI) 18-35 kg/m²
- Ability to understand and use the patient-controlled analgesia (PCA) device
- Ability to provide written informed consent
Exclusion Criteria:
- Refusal to participate
- Allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or ongoing anticoagulant therapy
- Chronic opioid use or opioid dependence
- Severe hepatic or renal insufficiency
- Pregnancy or breastfeeding
- Cognitive impairment or inability to communicate pain scores
- Body mass index (BMI) >35 kg/m²
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Intertransverse Process Block
|
A linear ultrasound probe will be positioned along the medial border of spinous processes level of the T10 thoracic vertebrae.Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T10 level, will be identified.
Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes.
Proper needle placement will be confirmed with the injection of 1-2 mmL isotonic saline demonstrating separation within the intertransverse plane.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.
|
|
Active Comparator: M-TAPA Block
|
A linear ultrasound probe will be positioned obliquely along the costal margin at the level of the 10th costal cartilage.
Anatomical landmarks, including the costal cartilage, rectus abdominis muscle, transversus abdominis muscle, and internal oblique muscle will be identified.
Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted toward the perichondrial plane beneath the 10th costal cartilage under ultrasound guidance.
Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity (VAS score)
Time Frame: 0, 1, 4, 8, 12, and 24 hours after surgery
|
Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores represent greater pain intensity.
|
0, 1, 4, 8, 12, and 24 hours after surgery
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Requirement for rescue analgesia
Time Frame: Within the first 24 hours postoperatively
|
Within the first 24 hours postoperatively
|
|
|
İncedence of postoperative nausea and vomiting
Time Frame: Within the first 24 hours postoperatively
|
Within the first 24 hours postoperatively
|
|
|
Total opioid consumption via patient-controlled analgesia (PCA)
Time Frame: Within the first 24 hours postoperatively
|
Within the first 24 hours postoperatively
|
|
|
Quality of recovery assessed using the QoR-15 questionnaire
Time Frame: At 24 hours postoperatively
|
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which ranges from 0 to 150, with higher scores indicating better recovery.
|
At 24 hours postoperatively
|
|
Potential Complications
Time Frame: Within the first 24 hours postoperatively
|
Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, or infection) will be recorded.
|
Within the first 24 hours postoperatively
|
|
Patient satisfaction
Time Frame: At 24 hours postoperatively
|
Patient satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied).
Higher scores indicate greater satisfaction.
|
At 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- ITPvsMTAPA-LH
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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