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Completed

NCT Number: NCT03741452

Transversalis Fascia Plane Block in Caesarean Section Patients

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maltepe University faculty of medicine

Istanbul, 34090, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transversalis fascia plane block

Other

patient controlled analgesia devices with tramadol

Other names: patient controlled analgesia

Primary outcomes

  1. 24 hours tramadol consumption

    Time frame: 24 hour

    tramadol consumptions for both group will be recorded

Secondary outcomes

  1. 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").

  2. Postoperative nausea and vomiting

    Time frame: 24 hours

    number of postoperative nasusea and vomiting after surgery will be questioned

Sponsors and collaborators

Lead sponsor

Maltepe University

Other

Registry information

Official study title

Evaluation of Ultrasound-guided Transversalis Fascia Plane Block for Postoperative Analgesia in Cesarean Section: A Prospective, Randomized, Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2018
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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