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Effect of Quadratus Lumborum Block in C/S

Primary Purpose

Postoperative Pain, Cesarean Section Complications, Block

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ultrasound guıded quadratus lumborum block
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • pregnancy with a gestation of 37-41 weeks parturients who were scheduled for elective cesarean delivery under general anesthesia
  • obtained patients informed consent

Exclusion Criteria:

  • inability to comprehend
  • bleeding diathesis
  • allergy to the study agents
  • localized infection
  • block failure

Sites / Locations

  • Healt Science University Bursa Training and Research Hospita

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

quadratus lumborum-2

quadratus lumborum-3

Arm Description

Outcomes

Primary Outcome Measures

Assesment of postoperative pain
measure of the visual analog scale at rest and dynamic after surgery

Secondary Outcome Measures

need of analgesic
total number of PCA demands

Full Information

First Posted
January 24, 2021
Last Updated
January 27, 2021
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04733313
Brief Title
Effect of Quadratus Lumborum Block in C/S
Official Title
Comparison of Ultrasound Guided Quadratus Lumborum Block-2 and Quadratus Lumborum Block-3 for Postoperative Pain in Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
August 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
to compare postoperative analgesic effects of USG guided QLB-2 and QLB-3 blocks after C/S. We hypothesized that QLB-3 may be more effective for pain relieving than QLB-2 after C/S.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Cesarean Section Complications, Block, Patient Satisfaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled
Masking
Participant
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
quadratus lumborum-2
Arm Type
Active Comparator
Arm Title
quadratus lumborum-3
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
ultrasound guıded quadratus lumborum block
Intervention Description
Administering local aneshtetic agent with a block needle using the in-plane technique, bilaterally. Lumbar interfascial triangle, where the middle lumbar fascia joins the deep lamina of the posterior layer on the lateral border of the erector spinae was targeted as the optimal point of injection.
Primary Outcome Measure Information:
Title
Assesment of postoperative pain
Description
measure of the visual analog scale at rest and dynamic after surgery
Time Frame
during 24 hour after surgery
Secondary Outcome Measure Information:
Title
need of analgesic
Description
total number of PCA demands
Time Frame
during 24 hour after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pregnancy with a gestation of 37-41 weeks parturients who were scheduled for elective cesarean delivery under general anesthesia obtained patients informed consent Exclusion Criteria: inability to comprehend bleeding diathesis allergy to the study agents localized infection block failure
Facility Information:
Facility Name
Healt Science University Bursa Training and Research Hospita
City
Bursa
State/Province
Yildirim
ZIP/Postal Code
16310
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Quadratus Lumborum Block in C/S

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