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

Primary Purpose

Pain, Postoperative Pain

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Bupivacaine 0.25% Injectable Solution

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Erzurum Regional Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group ESP

Group TFP

Arm Description

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

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

Outcomes

Primary Outcome Measures

Opioid Consumption

Opioid consumption postroperative period

Secondary Outcome Measures

Visual Analog Pain Score

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

Full Information

NCT ID

NCT05117307

First Posted

November 4, 2021

Last Updated

December 9, 2021

Sponsor

Erzurum Regional Training & Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05117307

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

June 15, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Erzurum Regional Training & Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group ESP

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group TFP

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine 0.25% Injectable Solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Opioid Consumption

Description

Opioid consumption postroperative period

Time Frame

Postoperative first 24 hours

Secondary Outcome Measure Information:

Title

Visual Analog Pain Score

Description

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

Time Frame

Postoperative first 24 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Erzurum Regional Training and Research Hospital

City

Erzurum

State/Province

Yakutiye

ZIP/Postal Code

25100

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omer Doymus, MD

Phone

00905070370397

omerdoymus@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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