- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04689633
Quadratus Lumborum Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy
March 2, 2021 updated by: Shadwa Rabea Mohamed, Minia University
Ultrasound-guided Bilateral Quadratus Lumborum Block Versus Erector Spinae Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
The patients were randomly allocated into 3 parallel groups of 20 patients in each group by using computer generated tables.
group(Q):received bilateral sonar-guided quadratus lumborum bolck using 20 ml bupivacaine 0.25%on each side.group(E): received bilateral ultrasound-guided erector spinae block using 20 ml bupivaciane 0.25%on each side.
group(C):didn't received any block
Study Overview
Detailed Description
on arrival to the operative room all patients were monitored with standared monitoring.
then IV cannula were inserted.
preoxygenation with 100% oxygen and induction of GA by 1mic/kg fentanyl and 2 mg/kg of 1%propofol.
endotracheal intubation was facilitated by 0.5mg/kg of atracurium.
isoflurane 1-2% with oxygen was used for anesthetic maintenance and 0.15 mg/kg intermittent doses of atracurium to maintain adequate muscle relaxation.
ventilation was controlled to maintain end tidal CO2 at 35-40 mmHg and SaO2 between 95-100.
after stabilization of the patient's hemodynamics and before surgical incision, quadratus lumborum and erector Spinae block were performed according to patient's group by the same anesthetist with the patient in lateral or prone position respectively.
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Minya, Egypt, 61111
- 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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American society of anesthesiologists(ASA) physical status1and2 scheduled for elective cholecystectomy under general anesthesia
Exclusion Criteria:
- Allergy to studed drugs
- morbid obesity
- patient refusal
- infection at the side of the bolck
- emergency laparoscopic cholecystectomy
- if laparoscopic procedure converted to open
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Quadratus lumborum block
received bilateral ultrasound-guided Quadratus lumborum block using 20 ml bupivacaine 0.25% on each side
|
bilateral ultrasound-guided posterior quadratus lumborum block was done in the lateral decubitus and linear or curvilinear probe was used according to the depth and placed in the midaxillary line in the transverse plane above the iliac crest
|
|
Active Comparator: Erector spinae block
received bilateral ultrasound-guided erector spinae block using 20 ml bupivacaine 0.25% on each side
|
bilateral ultrasound-guided posterior quadratus lumborum block was done in the lateral decubitus and linear or curvilinear probe was used according to the depth and placed in the midaxillary line in the transverse plane above the iliac crest
|
|
No Intervention: Control
didn't received any block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time of first postoperative analgesic request
Time Frame: 24 hours
|
first time that patient need analgesia and visual analogue scale more than 3
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Abeer Hassaneen, MD, Assistant Professor
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 15, 2019
Primary Completion (Actual)
December 15, 2019
Study Completion (Actual)
January 15, 2020
Study Registration Dates
First Submitted
December 29, 2020
First Submitted That Met QC Criteria
December 29, 2020
First Posted (Actual)
December 30, 2020
Study Record Updates
Last Update Posted (Actual)
March 4, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 135-12/2018
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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