Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transversalis Fascia Plane Block in Caesarean Section Patients

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: NCT03741452
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Asst. Prof. Serkan Tulgar, M.D., Maltepe University

Brief Summary:
Transversalis fascia plane block is a regional anesthesia technique described ten years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that transversalis fascia plane block could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral transversalis fascia plane block in cesarean section.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Other: transversalis fascia plane block Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Ultrasound-guided Transversalis Fascia Plane Block for Postoperative Analgesia in Cesarean Section: A Prospective, Randomized, Controlled Clinical Trial
Actual Study Start Date : November 26, 2018
Actual Primary Completion Date : February 19, 2019
Actual Study Completion Date : February 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transversalis fascia plane block
The transversalis fascia plane block will be administrated to this group at end of the surgery under general anesthesia. An intravenous patient-controlled analgesia device within tramadol will be given to the patients postoperatively.
Other: transversalis fascia plane block
patient controlled analgesia devices with tramadol
Other Name: patient controlled analgesia

No Intervention: Control group
In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia with tramadol. No block will be performed.



Primary Outcome Measures :
  1. 24 hours tramadol consumption [ Time Frame: 24 hour ]
    tramadol consumptions for both group will be recorded


Secondary Outcome Measures :
  1. Numeric rating scale for postoperative pain intensity [ Time Frame: 24 hours ]
    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  2. Postoperative nausea and vomiting [ Time Frame: 24 hours ]
    number of postoperative nasusea and vomiting after surgery will be questioned



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing cesarean section under general anesthesia ASA I-II

Exclusion Criteria:

  • patients undergoing cesarean section under neuraxial anesthesia morbidly obesity ASA III - IV infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic drugs

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): NCT03741452


Locations
Layout table for location information
Turkey
Maltepe University faculty of medicine
Istanbul, Turkey, 34090
Sponsors and Collaborators
Maltepe University

Publications:
Layout table for additonal information
Responsible Party: Asst. Prof. Serkan Tulgar, M.D., assoc professor in anesthesiology and reanimation, Maltepe University
ClinicalTrials.gov Identifier: NCT03741452     History of Changes
Other Study ID Numbers: TFPB in CS
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents