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
About this trial
This is an interventional prevention trial for Postoperative Pain
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
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
NCT ID
NCT04733313
First Posted
January 24, 2021
Last Updated
January 27, 2021
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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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