Back to resultsComaprison Between QLB and ESPB in Patients for PCNL Operation
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring pain management, Nephrolithotomy, QLB, ESPB, Erector Spinae, Quadratus Lumborum, Anesthesia, ultrasound, regional anethesia
Eligibility Criteria
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
Sites / Locations
- Assiut University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
QLB
ESPB
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Analgesia
Total opioid consumption during the first 48hours postoperatively.
Secondary Outcome Measures
Analgesia
first Analgesic request postoperatively.
episodes of nausea and vomiting
to investigate if there is or not.
Pain Scores using Visual Analog Scale (VAS) Scores
VAS is a scale to determine the patient's pain level.
ambulation time
time from the end of the surgery to the first time to out-of-bed activity
time of recovery of bowl movement
time from the end of the surgery to the first time of bowl movement
patient satisfaction with anesthesia
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)
postoperative length of hospital stay
till time of discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04277611
Brief Title
Comaprison Between QLB and ESPB in Patients for PCNL Operation
Official Title
Comparison Between Ultrasound Guided Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plane Block in Patients Undergoing Percutaneous Nephrolithotomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
pain management, Nephrolithotomy, QLB, ESPB, Erector Spinae, Quadratus Lumborum, Anesthesia, ultrasound, regional anethesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QLB
Arm Type
Active Comparator
Arm Description
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
Arm Title
ESPB
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Analgesia
Description
Total opioid consumption during the first 48hours postoperatively.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Analgesia
Description
first Analgesic request postoperatively.
Time Frame
24 hours
Title
episodes of nausea and vomiting
Description
to investigate if there is or not.
Time Frame
within 24 hours postoperative
Title
Pain Scores using Visual Analog Scale (VAS) Scores
Description
VAS is a scale to determine the patient's pain level.
Time Frame
24 hours postoperative.
Title
ambulation time
Description
time from the end of the surgery to the first time to out-of-bed activity
Time Frame
5 days postoperative
Title
time of recovery of bowl movement
Description
time from the end of the surgery to the first time of bowl movement
Time Frame
5 days postoperative
Title
patient satisfaction with anesthesia
Description
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)
Time Frame
48 hours postoperative.
Title
postoperative length of hospital stay
Description
till time of discharge
Time Frame
within 2 weeks postoperative.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Thabet, Lecturer
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alaa Attia, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut University Hospitals
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Comaprison Between QLB and ESPB in Patients for PCNL Operation
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