NCT03741452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2019

Completed
Last Updated

February 25, 2019

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

November 11, 2018

Last Update Submit

February 22, 2019

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • 24 hours tramadol consumption

    tramadol consumptions for both group will be recorded

    24 hour

Secondary Outcomes (2)

  • Numeric rating scale for postoperative pain intensity

    24 hours

  • Postoperative nausea and vomiting

    24 hours

Study Arms (2)

Transversalis fascia plane block

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

transversalis fascia plane blockOTHER

patient controlled analgesia devices with tramadol

Also known as: patient controlled analgesia
Transversalis fascia plane block

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University faculty of medicine

Istanbul, 34090, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 29689328BACKGROUND

  • 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.

    PMID: 29164530BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc professor in anesthesiology and reanimation

Study Record Dates

First Submitted

November 11, 2018

First Posted

November 14, 2018

Study Start

November 26, 2018

Primary Completion

February 19, 2019

Study Completion

February 22, 2019

Last Updated

February 25, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)