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Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03811067
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Hadi Ufuk Yörükoğlu, Kocaeli University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Transversus abdominis plane block Procedure: Rectus sheath block Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group
Active Comparator: TAP group
Transversus abdominis plane block administered group
 Procedure: Transversus abdominis plane block
Transversus abdominis plane block will be performed bilaterally after the surgery.
Active Comparator: RS group
Rectus sheath block administered group
 Procedure: Rectus sheath block
Rectus sheath block will be performed bilaterally after the surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: Postoperative 24th hour. ]
    Morphine consumption (mg) of patients with patient controlled device

  2. NRS score [ Time Frame: Postoperative 24th hour ]
    Numerating rating scale of patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811067


Locations
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Turkey
Kocaeli University
Kocaeli, Turkey, 41350
Sponsors and Collaborators
Kocaeli University
Investigators
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Principal Investigator: Hadi Ufuk MD Yörükoğlu Kocaeli University
More Information
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Responsible Party: Hadi Ufuk Yörükoğlu, Principal investigator, Kocaeli University
ClinicalTrials.gov Identifier: NCT03811067    
Other Study ID Numbers: KAEK 2017/348
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hadi Ufuk Yörükoğlu, Kocaeli University:
Postoperative pain
Transversus abdominis plane block
Rectus sheath block
Cesarean delivery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations