- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05541588
Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Analgesia After Abdominal Hysterectomy
September 15, 2022 updated by: Khaled Abdou, Ain Shams University
Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Analgesia After Abdominal Hysterectomy; A Randomized Comparative Study
The aim of this study is to compare the analgesic efficacy of erector spinae plane block and quadratus lumborum block after abdominal hysterectomy surgery and postoperative opioid consumption.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
64
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
-
-
-
Cairo, Egypt
- Recruiting
- Ain Shams Univerisity
-
Contact:
- Khaled Abdou, MD
- Phone Number: 202-01001958665
- Email: khaledabdou@med.asu.edu.eg
-
Principal Investigator:
- Khaled Abdou, MD
-
Sub-Investigator:
- Marrwa Salem, MD
-
-
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
38 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients with American Society of Anesthesiologists (ASA) physical status 1-3.
- scheduled for abdominal hysterectomy surgery.
Exclusion Criteria:
- History of allergy to the medications used in the study.
- Contraindication to regional anesthesia as coagulopathy, local infection.
- Severe hepatic impairment (child C).
- Sever Renal dysfunction (creatinine clearance < 30).
- Psychiatric or mental disorder affecting patient ability to interpret VAS score.
- Body mass index (BMI) ≥ 40 or ≤ 18 kg/m2.
- ASA IV.
- Patient refusal.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ESPB
Erector Spinae Plane Block group
|
ultrasound guided nerve block
|
Active Comparator: QLB
Quadratus Lumborum Block group
|
ultrasound guided nerve block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative pain
Time Frame: 24 hours
|
Post-operative pain severity assessed by visual analog scale (VAS) (range from 0-10., 0 no pain, 10 worst pain ).
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative post-operative opioid consumption
Time Frame: 24 hours
|
opioid consumption
|
24 hours
|
The onset of 1st analgesic request
Time Frame: 24 hours
|
time needed for 1st request of rescue analgesia
|
24 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of complications
Time Frame: 24 hours
|
postoperative nausea and vomiting(PONV), hematoma, local anaesthetic toxicity (LAT)
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 7, 2022
Primary Completion (Anticipated)
January 1, 2023
Study Completion (Anticipated)
January 1, 2023
Study Registration Dates
First Submitted
September 13, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (Actual)
September 15, 2022
Study Record Updates
Last Update Posted (Actual)
September 19, 2022
Last Update Submitted That Met QC Criteria
September 15, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- ASUKH1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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