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NCT04172727 Clinical Trial

Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Section

Pain, Acute Clinical Trial

Official title:
Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Sections: A Randomized Placebo-Controlled Double-Blind Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04172727
Other study ID # AUTF ANESTHESIAOBSTETRIC
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2019
Est. completion date June 1, 2019

Study information
Verified date November 2019
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Postoperative pain management is critical for the fulfillment of the maternal duties. The transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12 and L1 dermatomes. The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing cesarean section (CS) under spinal anesthesia.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- aged between 18 and 45

- American Society of Anesthesiologists (ASA) physical score I or II

Exclusion Criteria:

- Patients who received general anesthesia

- hypersensitivity to the agents to be used

- body mass index (BMI) greater than 35 kg/m2

- coagulopathy

- local infections

- opioid addiction

- pregnancy-related hypertension or diabetes mellitus

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bupivacaine Hcl 0.25% Inj
ultrasound-guided bilateral TFP block with 20 mL of 0.25% bupivacaine
• saline 0.9%
ultrasound-guided bilateral TFP block with 20 mL of saline 0.9%

Locations
Country Name City State
Turkey Ali Ahiskalioglu Erzurum

Sponsors (1)
Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. — View Citation

Serifsoy TE, Tulgar S, Selvi O, Senturk O, Ilter E, Peker BH, Ozer Z. Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2020 Feb;59:56-60. doi: 10.1016/j.jclinane.2019.06.025. Epub 2019 Jun 27. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary opioid consumption morphine consumption first 24hour Postoperative first 24hour
Secondary pain scores Visual Analogue Scale (0-10) postoperative 0-24 hours
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