- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06939725
Transverse Abdominis Plane (TAP) Block Versus Transversalis Fascia Plane Block (TFPB) After Cesarean Delivery
April 27, 2025 updated by: Samsun University
Outcomes of Postoperative Analgesia Protocols and Their Impact on Recovery Quality in Patients Undergoing Cesarean Section
Postoperative analgesia treatment methods are applied to the living in the operating room.
It is a routine part of the process of these applications.
It is necessary from medical and ethical perspectives.
Postoperative analgesia applications are started in the preoperative period and continue in the postoperative period.
The analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist.
The scientifically accepted developed method is multimodal analgesia protocols.
These protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as Transversalis Fascial Plane Block (TFPB) and Transversus Abdominis Plane (TAP) Block).
The aim of this study is to continue the analgesia protocols applied in cesarean section surgeries on the first 24-hour pain scores, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Postoperative analgesia treatment methods are applied to the living in the operating room.
It is a routine part of the process of these applications.
It is necessary from medical and ethical perspectives.
Postoperative analgesia applications are started in the preoperative period and continue in the postoperative period.
The analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist.
The scientifically accepted developed method is multimodal analgesia protocols.
These protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as Transversalis Fascial Plane Block (TFPB) and Transversus Abdominis Plane (TAP) Block).
In this study, transversus abdominis plane block or transversalis fascial plane block was applied to the participants immediately after surgery.
The aim is to continue the analgesia protocols applied to the cesarean section surgeries on the pain scores in the first 24 hours, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.
Study Type
Observational
Enrollment (Actual)
67
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
İ̇lkadim
-
Samsun, İ̇lkadim, Turkey, 55000
- Samsun University, Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Participants who underwent elective cesarean section and received regional anesthesia for postoperative analgesia
Description
Inclusion Criteria:
- >18 years
- Term pregnancies (37-42 weeks) and those planned to undergo elective cesarean delivery under spinal anesthesia
Exclusion Criteria:
- <18 years
- Emergency surgery
- BMI > 35 kg/m2 or anatomic conditions that would preclude spinal anesthesia
- Increased susceptibility to bleeding or coagulation disorders (platelet count below 80,000× 10^3/mm^3 or INR > 1.5)
- Known allergy to any drug, such as local anesthetics, opioids, or NSAIDs
- Other relevant maternal or neonatal clinical conditions requiring treatment and at the discretion of the investigators, such as gestational hypertension, impaired renal or hepatic function, postpartum hemorrhage
- Chronic pain conditions and concomitant use of analgesics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Transversus abdominis plane block was performed immediately after cesarean section.
|
We apply different nerve blocks to patients for pain relief after cesarean surgery.
Transversus abdominis plane block was applied to this group
|
|
Group 2
Transversalis fascial plane block was performed immediately after cesarean section
|
We apply different nerve blocks to patients for pain relief after cesarean surgery.
Transversalis Fascia Plane Block was applied to this group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain
Time Frame: postoperative 24 hours
|
Pain levels of patients will be evaluated with the Numerical Pain Scale (NRS) in the first 24 hours postoperatively. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" |
postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ObsQoR-10
Time Frame: Postoperative 24 hours
|
The ObsQoR-10 questionnaire consists of 10 questions that assess the patient-reported quality of recovery in obstetric patients' postoperative period using an 11-point Likert scale (0 = strongly negative; 10 = strongly positive) that points to a minimum score of 0 (worst possible recovery) and a maximum score of 100 (best possible recovery)
|
Postoperative 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: SEVDA AKDENIZ, Assoc Prof, Samsun University
- Study Director: HATİCE SELÇUK KUŞDERCİ, Asst. Prof., Samsun University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2025
Primary Completion (Actual)
March 31, 2025
Study Completion (Actual)
March 31, 2025
Study Registration Dates
First Submitted
April 15, 2025
First Submitted That Met QC Criteria
April 15, 2025
First Posted (Actual)
April 23, 2025
Study Record Updates
Last Update Posted (Actual)
April 30, 2025
Last Update Submitted That Met QC Criteria
April 27, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOKAEK 2024/22/14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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