- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04277611
Comaprison Between QLB and ESPB in Patients for PCNL Operation
September 4, 2022 updated by: Peter Bassem Halim Gadelsyed, Assiut University
Comparison Between Ultrasound Guided Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plane Block in Patients Undergoing Percutaneous Nephrolithotomy
comparing the subcostal oblique Quadratus Lumborum block and the Erector Spinae plane block in patients undergoing percutaneous nephrolithotomy operation to get the best and longest postoperative analgesic effect.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Here the investigators are going to compare between the Anterior approach for the subcostal oblique Quadratus Lumborum block (QLB) and the Erector Spinae Plane Block (ESPB) to determine their level of spread and their value in controlling postoperative pain in patients scheduled for Percutaneous Nephrolithotomy surgery.
We hypothesized that quadratus lumborum is not inferior regarding the duration of analgesia when compared to erector spinae in patients undergoing percutaneous nephrolithotomy under general anesthesia.
Study Type
Interventional
Enrollment (Actual)
92
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
-
-
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Assiut, Egypt, 71111
- Assiut University Hospitals
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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
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Both sex
- Age: 18-60
- ASA (American Society of Anesthesiologists) class I and II
- Elective surgery
- Patients undergoing PNL surgery
Exclusion Criteria:
- Patient's refusal
- Allergy or contraindications to drugs used in the study
- Emergency surgery
- Psychiatric disorders
- Severely co-morbid patients
- Inflammation or infection over injection site
- Bleeding diathesis; INR more than 1.5 and Platelet count less than 100,000/mm3
- Peripheral neuropathy
- Obese patients BMI ≥35
- Patients on previous opioid therapy
- Pre-operative haemoglobin <10 mg/dl
- Inability to properly describe postoperative pain to investigators
- Coagulation abnormalities
- History of drug addiction or alcohol abuse
- History of Previous renal surgery
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: QLB
The patient is in the prone position, an ultrasound probe is placed in a transverse, oblique, and paramedian orientation approximately lateral to the posterior axillary line.
The needle is then inserted in-plane from the medial side of the transducer and advanced laterally to enter the interfascial plane between the Quadratus Lumborum muscle and the kidney.
We confirmed that the local anesthetic appeared to press down the kidney in the ultrasound image
|
patients undergo general anesthesia,will be put in prone position.In case of Quadratus Lumborum block 1-3 mL of normal saline is injected to produce hydro-dissection and spread cranially between the QL and kidney.
The corresponding ultrasonographic sign is a lunar-shaped hypo-echoic fluid collection observed between the long axis of the kidney and QL muscle.
20 ml Bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is administered.
In case of the ESPB The location of the needle tip is confirmed by hydro-dissection and after visualizing the fluid spread lifting the Erector Spinae off the transverse process, 20 ml bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is injected.
|
Active Comparator: ESPB
Using aseptic technique, an ultrasound probe is placed at the T9 vertebral level.
After identifying the ribs and sliding towards the midline in a longitudinal parasagittal orientation, the overlying Erector Spinae is identified by visualization of the transition between the rib and transverse apophysis a block needle is inserted in plane with ultrasound beam and is advanced in a cephalo-caudal direction until the tip contacted the transverse process.
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patients undergo general anesthesia,will be put in prone position.In case of Quadratus Lumborum block 1-3 mL of normal saline is injected to produce hydro-dissection and spread cranially between the QL and kidney.
The corresponding ultrasonographic sign is a lunar-shaped hypo-echoic fluid collection observed between the long axis of the kidney and QL muscle.
20 ml Bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is administered.
In case of the ESPB The location of the needle tip is confirmed by hydro-dissection and after visualizing the fluid spread lifting the Erector Spinae off the transverse process, 20 ml bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is injected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesia
Time Frame: 48 hours
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Total opioid consumption during the first 48hours postoperatively.
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48 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesia
Time Frame: 24 hours
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first Analgesic request postoperatively.
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24 hours
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episodes of nausea and vomiting
Time Frame: within 24 hours postoperative
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to investigate if there is or not.
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within 24 hours postoperative
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Pain Scores using Visual Analog Scale (VAS) Scores
Time Frame: 24 hours postoperative.
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VAS is a scale to determine the patient's pain level.
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24 hours postoperative.
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ambulation time
Time Frame: 5 days postoperative
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time from the end of the surgery to the first time to out-of-bed activity
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5 days postoperative
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time of recovery of bowl movement
Time Frame: 5 days postoperative
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time from the end of the surgery to the first time of bowl movement
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5 days postoperative
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patient satisfaction with anesthesia
Time Frame: 48 hours postoperative.
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Patient satisfaction with anesthesia was assessed using a 5-point scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied)
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48 hours postoperative.
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postoperative length of hospital stay
Time Frame: within 2 weeks postoperative.
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till time of discharge
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within 2 weeks postoperative.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amr Thabet, Lecturer, Assiut University
- Study Chair: Alaa Attia, Professor, Assiut University
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 20, 2021
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
February 18, 2020
First Submitted That Met QC Criteria
February 19, 2020
First Posted (Actual)
February 20, 2020
Study Record Updates
Last Update Posted (Actual)
September 7, 2022
Last Update Submitted That Met QC Criteria
September 4, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QLB and ESPB comparison
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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