- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06386978
Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section
Examination of the Postoperative Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section Surgeries Performed Under Spinal Anesthesia
This study was designed as a prospective, randomized observational clinical trial.
A total of 90 adult women were included in the study performed elective cesarean section.
After excluding patients, the care of 90 was included and 3 of these amounts were reserved.
TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3); Spinal Anesthesia + No block;
Study Overview
Status
Conditions
Detailed Description
This study was designed as a prospective, randomized observational clinical trial. Erciyes University Clinical Research Ethics Board 2024/209.
All participants in the study were adults and their information was confirmed in writing. Preoperative anesthesia assessment was made by an anesthetic injection, cesarean section surgeries for 90 women were planned to be performed on elective conditions among those registered between May 2024 and May 2025. ASA score, anesthesia method, age, weight, height, TAP block group (Group I) or TFP block group (Group II), Control group (Group III) :
Duration of spinal anesthesia, time of first analgesic request, total analgesic consumption for 24-48 hours, VAS score, additional analgesics, patient satisfaction, possible postoperative bleeding, vomiting, heat retention and other interruptions were recorded in the patients.
Those who were allergic to local anesthetics, steroid treatment areas, ASA III, ASA IV and ASA V, patients under the age of 18, preeclampsia, eclampsia, placenta percreta and accreta complications and emergency hospitals were excluded from the study. After excluding patients, the care of 90 was included and 3 of these amounts were reserved.
TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3): Spinal Anesthesia + No block; At the end of the surgery, TAP (Transverse Abdominis Plane Block) Block or TFP (Transversalis Fascia Plane Block) block was performed under aseptic conditions under ultrasonography guidance.
TAP (Transverse Abdominis Plane Block) Block for Group 1 patients and TFP (Transversalis Fascia Plane Block) block for Group 2 patients on both sides after negative aspiration, with 20 ml 0.25% bupivacaine (Marcaine®, Astra-Zeneca, Turkey) under ultrasonography guidance. It was done under aseptic conditions.
Patients who did not accept both blocks were included in Group 3 (Control group).
All patients were trained on visual analog score (VAS) by the anesthesia assistant during the preoperative evaluation. VAS used for pain assessment, a 10 cm long horizontal line was used.
From 0= (no pain) to 10= (most severe pain).
PCA morphine administration to all patients: The hourly limit was set as 4 mg, and the repeat limit was set as 10 minutes. If the 1 mg IV morphine bolus dose was not sufficient, it was planned to repeat it after 10 minutes, and if it was still not sufficient, paracetamol and diclofenac were planned to be administered.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kayseri, Turkey (Türkiye), 38039
- Erciyes University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA I and ASA II,
- Pregnant patients accepting spinal anesthesia and procedure
Exclusion Criteria:
- Those who are allergic to local anesthetics,
- Those receiving steroid treatment,
- ASA III, ASA IV and ASA V,
- Patients under the age of 18,
- Patients with preeclampsia,
- Eclampsia,
- Placenta percreta and accreta and its complications,
- Emergency patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TAP Group
TAP (Transverse Abdominis Plane Block) Block was performed in Group 1 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance.
|
Spinal Anesthesia + TAP block
|
|
Active Comparator: TFP Group
TFP (Transversalis facia plane block ) Block was performed in Group 2 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance.
|
Spinal Anesthesia + TFP block
|
|
Active Comparator: Control Group
Patients in the Third group will be considered the control group and no block will be performed
|
Spinal anesthesia + No block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS score evaluation
Time Frame: 1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period.
|
A research asistant, bilinded to the group allocation, interviewedpatients and collected data in the24 hours postoperative period.
Verbal Analog Pain Scale Score value will be the lowerst 0 and the highest 10.
All the highest value, the patient's pain is at its maximum and whether higher scores mean worse outcome.
|
1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time until the first analgesic request
Time Frame: 1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period
|
These were the time until the first analgesic request, the number of patients requiring additional analgesics, the general dose of additional analgesic consumption and complications.
|
1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction/Dissatisfaction
Time Frame: 1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period
|
A scale of Satisfaction/Dissatisfaction was used to evaluate the patient satisfaction rate.
|
1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kudret Dogru, Prof., TC Erciyes University
Publications and helpful links
General Publications
- Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
- Srivastava U, Verma S, Singh TK, Gupta A, Saxsena A, Jagar KD, Gupta M. Efficacy of trans abdominis plane block for post cesarean delivery analgesia: A double-blind, randomized trial. Saudi J Anaesth. 2015 Jul-Sep;9(3):298-302. doi: 10.4103/1658-354X.154732.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 2024/209
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
product manufactured in and exported from the U.S.
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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