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Transversalis Fascia Plane Block in Caesarean Section Patients

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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

Tracking Information
First Submitted Date  ICMJE November 11, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE November 26, 2018
Actual Primary Completion Date February 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
24 hours tramadol consumption [ Time Frame: 24 hour ]
tramadol consumptions for both group will be recorded
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03741452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • 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").
  • Postoperative nausea and vomiting [ Time Frame: 24 hours ]
    number of postoperative nasusea and vomiting after surgery will be questioned
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Numeric rating scale [ Time Frame: 24 hours ]
    Numeric rating scales will be recorded
  • Postoperative nausea and vomiting [ Time Frame: 24 hours ]
    PONV after surgery will be questioned
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transversalis Fascia Plane Block in Caesarean Section Patients
Official Title  ICMJE Evaluation of Ultrasound-guided Transversalis Fascia Plane Block for Postoperative Analgesia in Cesarean Section: A Prospective, Randomized, Controlled Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE Other: transversalis fascia plane block
patient controlled analgesia devices with tramadol
Other Name: patient controlled analgesia
Study Arms  ICMJE
  • 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.
    Intervention: Other: transversalis fascia plane block
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2019)
70
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2018)
30
Actual Study Completion Date  ICMJE February 22, 2019
Actual Primary Completion Date February 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03741452
Other Study ID Numbers  ICMJE TFPB in CS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Asst. Prof. Serkan Tulgar, M.D., Maltepe University
Study Sponsor  ICMJE Maltepe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Maltepe University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP