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Comparison of Transversalis Fascia Plane Block and Erector Spinae Plane Blocks in Cesarean Section

Sponsor
Erzurum Regional Training & Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05117307
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
6.9
Anticipated Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cesarean section is one of the most common major surgical procedures performed worldwide,, Post-cesarean analgesia should provide adequate pain control while allowing the mother to remain active to meet the needs of the baby. Insufficient analgesia after cesarean section may be associated with acute postoperative pain, chronic pain, higher opioid consumption, delayed functional capacity, and postpartum depression. Techniques such as neuraxial techniques, oral and intravenous agents, wound infiltration, and behavioral therapy can be used in the treatment of post-cesarean pain pain. In addition, Transversus abdominis plane block (TAP), Quadratus Lumborum block (QLB), Erector Spina block (ESP), Transversalis Fascia plane block (TFP) are used safely under ultrasound guidance. In this study, it was aimed primarily to examine the effects of TFP and ESP blocks on pain scores, and secondarily to evaluate analgesic consumption.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine 0.25% Injectable Solution
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of Transversalis Fascia Plane Block and Erector Spinae Plane Blocks in Cesarean Section
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group ESP

Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side

Drug: Bupivacaine 0.25% Injectable Solution
Ultrasound-guided block with 20 ml %0.25 bupivacaine, per side
Active Comparator: Group TFP

Ultrasound-guided Transversalis Fascia Plane Block block with 20 ml %0.25 bupivacaine, per side

Drug: Bupivacaine 0.25% Injectable Solution
Ultrasound-guided block with 20 ml %0.25 bupivacaine, per side

Outcome Measures

Primary Outcome Measures

  1. Opioid Consumption [Postoperative first 24 hours]

    Opioid consumption postroperative period

Secondary Outcome Measures

  1. Visual Analog Pain Score [Postoperative first 24 hours]

    Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Between 18-50 years

  • Cesarean Section

Exclusion Criteria:

  • Cesarean Section under general anesthesia

  • emergency cases

  • those with a body mass index greater than 35 kg/m2

  • coagulopathy

  • local infection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erzurum Regional Training and Research Hospital Erzurum Yakutiye Turkey 25100

Sponsors and Collaborators

  • Erzurum Regional Training & Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Omer Doymus, Medical Doctor, Erzurum Regional Training & Research Hospital
ClinicalTrials.gov Identifier:
NCT05117307
Other Study ID Numbers:
  • TFP vs ESP on C/S
First Posted:
Nov 11, 2021
Last Update Posted:
Dec 30, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative
Bupivacaine

Study Results

No Results Posted as of Dec 30, 2021