- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811067
Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery
July 22, 2019 updated by: Hadi Ufuk Yörükoğlu, Kocaeli University
Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial
Importance of effective postoperative pain management is well known.
The undesired effects of pain can be prevented with multimodal analgesia for the patient.
Overall, for cesarean delivery, interaction between the mother and her newborn baby can be provided earlier.
Many regional anesthesia techniques can be prefferred after cesarean delivery.
Aim of the study is to compare the postoperative analgesia effects of transversus abdominis plane block and rectus sheath block after elective cesarean delivery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
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
-
-
-
Kocaeli, Turkey, 41350
- Kocaeli University
-
-
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
ASA I-II patients Patients undergo elective cesarean delivery Gestation period between 37-40 weeks
Exclusion Criteria:
obesity (body mass index >35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
|
|
Active Comparator: TAP group
Transversus abdominis plane block administered group
|
Transversus abdominis plane block will be performed bilaterally after the surgery.
|
Active Comparator: RS group
Rectus sheath block administered group
|
Rectus sheath block will be performed bilaterally after the surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine consumption
Time Frame: Postoperative 24th hour.
|
Morphine consumption (mg) of patients with patient controlled device
|
Postoperative 24th hour.
|
NRS score
Time Frame: Postoperative 24th hour
|
Numerating rating scale of patients
|
Postoperative 24th hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hadi Ufuk MD Yörükoğlu, Kocaeli 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)
April 25, 2019
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 15, 2019
Study Registration Dates
First Submitted
January 18, 2019
First Submitted That Met QC Criteria
January 18, 2019
First Posted (Actual)
January 22, 2019
Study Record Updates
Last Update Posted (Actual)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 22, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEK 2017/348
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
Clinical Trials on Postoperative Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on Transversus abdominis plane block
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedPostoperative Complications | Postoperative Pain | Analgesia | Regional Anesthesia MorbidityTurkey
-
Mackay Memorial HospitalRecruitingLaparoscopy | Anesthesia and Analgesia | Autonomic Nervous System | Nerve Block | EEGTaiwan
-
Ain Shams UniversityRecruiting
-
Benaroya Research InstituteCompletedPost-Operative PainUnited States
-
Cairo UniversityUnknown
-
Nemours Children's ClinicCompletedAnesthesia, Recovery PeriodUnited States
-
Cairo UniversityCompleted
-
Uludag UniversityCompleted
-
Istanbul Medeniyet UniversityRecruitingSubcostal Transversus Abdominis Plane BlockTurkey
-
Nordsjaellands HospitalCompletedPostoperative PainDenmark