Transversalis Fascia Plane Block in Caesarean Section Patients

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741452
• Other study ID #: TFPB in CS
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: February 22, 2019

Study information

• Verified date: November 2018
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 22, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• transversalis fascia plane block
patient controlled analgesia devices with tramadol

Locations

Country	Name	City	State
Turkey	Maltepe University faculty of medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours tramadol consumption	tramadol consumptions for both group will be recorded	24 hour
Secondary	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").	24 hours
Secondary	Postoperative nausea and vomiting	number of postoperative nasusea and vomiting after surgery will be questioned	24 hours