Transversalis Fascia Plane Block in Caesarean Section Patients

NCT ID: NCT03741452

Last Updated: 2019-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2019-02-22

Brief Summary

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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

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

transversalis fascia plane block

Intervention Type OTHER

patient controlled analgesia devices with tramadol

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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transversalis fascia plane block

patient controlled analgesia devices with tramadol

Intervention Type OTHER

Other Intervention Names

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patient controlled analgesia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maltepe University

OTHER

Sponsor Role lead

Responsible Party

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Asst. Prof. Serkan Tulgar, M.D.

assoc professor in anesthesiology and reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maltepe University faculty of medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29689328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29164530 (View on PubMed)

Other Identifiers

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TFPB in CS

Identifier Type: -

Identifier Source: org_study_id

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