Comparison of the Effects of QLB 2 and QLB 3 on Post-operative Analgesia in Cesarean Section Surgery
April 15, 2021 updated by: Caner Genç, Ondokuz Mayıs University
Comparison of the Effects of Quadratus Lumborum Block 2 and 3 (QLB 2 and QLB 3) on Post-operative Analgesia in Cesarean Section Surgery
This study evaluates the post-operative analgesic effects of quadratus lomborum block 2 and 3 (QLB 2, 3) in patients having cesarean section with spinal anesthesia.
Spinal anesthesia will be performed to all patients for the surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this study, patients are divided into two groups. After the spinal anesthesia is performed and cesarean section surgery is over; QLB 2 block will be performed to patients in Group A ; while QLB 3 block will be performed to patients in Group B.
In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Group A - Patients in group A will have QLB 2 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Group B - Patients in group B will have QLB 3 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Other
-
Samsun, Other, Turkey, 55200
- Ondokuz Mayıs University Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Being pregnant for at least 37 weeks
- Planning an elective cesarean operation
- Being between the ages of 18-45
Exclusion Criteria:
- ASA 3-4 patients with comorbitidies (Serious renal, cardiac, hepatic disease)
- Being operated with general anesthesia
- Obesity (> 100 kg, BMI> 35 kg / m2)
- Contraindication of regional anesthesia (quagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
- Hypersensitivity to local anesthetics or a history of allergy
- Patients with a history of opioid use longer than four weeks
- Patients with psychiatric disorders
- Patients with anatomic deformity
- Patients who do not want to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Quadratus Lumborum Block 2
Quadratus Lumborum Block 2 (QLB 2) will be performed the patients in Group A after the cesarean section surgery.
Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively
|
The effects of QLB 2, 3 interfascial plane blocks on post-operative analgesia after cesarean section surgery
Other Names:
|
|
Active Comparator: Quadratus Lumborum Block 3
Quadratus Lumborum Block 3 (QLB 3) will be performed the patients in Group B after the cesarean section surgery.
Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively
|
The effects of QLB 2, 3 interfascial plane blocks on post-operative analgesia after cesarean section surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption in the first 24 hours after surgery
Time Frame: 1 day
|
Morphine consumption in the first 24 hours will be counted by IV patient controlled analgesia device (PCA).
Patients will be able to request opioids via PCA device when the nrs score is above 4.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative acute pain
Time Frame: 1 day
|
Pain status will be evaluated based on NRS scores.
Pain status will be evaluated at 1, 3, 6, 9, 12, 18, 24.
hours after surgery.
Each NRS is scores 0-10.
(0=no pain ; 10=pain as bad as can be)
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ERSİN KÖKSAL, MD, Ondokuz Mayıs University Faculty of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2020
Primary Completion (Actual)
September 15, 2020
Study Completion (Actual)
September 15, 2020
Study Registration Dates
First Submitted
April 23, 2020
First Submitted That Met QC Criteria
April 23, 2020
First Posted (Actual)
April 28, 2020
Study Record Updates
Last Update Posted (Actual)
April 19, 2021
Last Update Submitted That Met QC Criteria
April 15, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QL20011990
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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