Transversalis Fascia Plane Block in Caesarean Section Patients

Sponsor
Maltepe University (Other)
Overall Status
Completed
CT.gov ID
NCT03741452
Collaborator
(none)
70
1
2
2.9
24.2

Study Details

Study Description

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
  • Other: transversalis fascia plane block
N/A

Study Design

Study Type:
Interventional
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 :
Nov 26, 2018
Actual Primary Completion Date :
Feb 19, 2019
Actual Study Completion Date :
Feb 22, 2019

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. 24 hours tramadol consumption [24 hour]

      tramadol consumptions for both group will be recorded

    Secondary Outcome Measures

    1. Numeric rating scale for postoperative pain intensity [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 [24 hours]

      number of postoperative nasusea and vomiting after surgery will be questioned

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maltepe University faculty of medicine Istanbul Turkey 34090

    Sponsors and Collaborators

    • Maltepe University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Asst. Prof. Serkan Tulgar, M.D., assoc professor in anesthesiology and reanimation, Maltepe University
    ClinicalTrials.gov Identifier:
    NCT03741452
    Other Study ID Numbers:
    • TFPB in CS
    First Posted:
    Nov 14, 2018
    Last Update Posted:
    Feb 25, 2019
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 25, 2019