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Transversalis Fascia Plane Block in Caesarean Section Patients

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
transversalis fascia plane block
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maltepe University faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transversalis fascia plane block

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

24 hours tramadol consumption
tramadol consumptions for both group will be recorded

Secondary Outcome Measures

Numeric rating scale for postoperative pain intensity
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
number of postoperative nasusea and vomiting after surgery will be questioned

Full Information

First Posted
November 11, 2018
Last Updated
February 22, 2019
Sponsor
Maltepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03741452
Brief Title
Transversalis Fascia Plane Block in Caesarean Section Patients
Official Title
Evaluation of Ultrasound-guided Transversalis Fascia Plane Block for Postoperative Analgesia in Cesarean Section: A Prospective, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
February 19, 2019 (Actual)
Study Completion Date
February 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transversalis fascia plane block
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia with tramadol. No block will be performed.
Intervention Type
Other
Intervention Name(s)
transversalis fascia plane block
Other Intervention Name(s)
patient controlled analgesia
Intervention Description
patient controlled analgesia devices with tramadol
Primary Outcome Measure Information:
Title
24 hours tramadol consumption
Description
tramadol consumptions for both group will be recorded
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Numeric rating scale for postoperative pain intensity
Description
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").
Time Frame
24 hours
Title
Postoperative nausea and vomiting
Description
number of postoperative nasusea and vomiting after surgery will be questioned
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Maltepe University faculty of medicine
City
Istanbul
ZIP/Postal Code
34090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29689328
Citation
Tulgar S, Serifsoy TE. Transversalis fascia plane block provides effective postoperative analgesia for cesarean section: New indication for known block. J Clin Anesth. 2018 Aug;48:13-14. doi: 10.1016/j.jclinane.2018.04.006. Epub 2018 Apr 22. No abstract available.
Results Reference
background
PubMed Identifier
29164530
Citation
Sondekoppam RV, Ip V, Johnston DF, Uppal V, Johnson M, Ganapathy S, Tsui BCH. Ultrasound-guided lateral-medial transmuscular quadratus lumborum block for analgesia following anterior iliac crest bone graft harvesting: a clinical and anatomical study. Can J Anaesth. 2018 Feb;65(2):178-187. doi: 10.1007/s12630-017-1021-y. Epub 2017 Nov 21.
Results Reference
background

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Transversalis Fascia Plane Block in Caesarean Section Patients

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