Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children
Primary Purpose
Postoperative Pain, Acute
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ultrasound-guided Erector Spinae Plane Block
Ultrasound-guided Quadratus Lumborum Block
Ultrasound Machine
Echogenic needle
Fentanyl
Pethidine
Sponsored by
About this trial
This is an interventional other trial for Postoperative Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- American society of anesthesiologists (ASA) class I and II
- Children undergoing unilateral open renal surgeries
Exclusion Criteria:
- Parents refusal for the block
- Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%)
- Skin lesion, wounds or infection at the puncture site.
- Known allergy to local anesthetic drugs
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Erector spinae plane block (ESPB) group
Quadratus lumborum block (QLB) group
Arm Description
30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
Outcomes
Primary Outcome Measures
Time to first postoperative rescue analgesia
Time in minutes when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score exceeds 6 for the first time. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
Secondary Outcome Measures
Total opioid analgesic consumption in the first 12 hours postoperative period
when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score ˃ 6 in the first 12 hours postoperatively. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
Intraoperative mean arterial blood pressure
measured from induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
Intraoperative heart rate
measured before and after induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
Postoperative pain score
measured at time of patient transfer to the PACU, 15, 30 mins, 1 ,2 , 4 ,6 ,12 hours after surgery
Block performance time
Time to perform ultrasound guided nerve block
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05386121
Brief Title
Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children
Official Title
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
Open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery & early discharge of patients. Side effects of systemic opioids, as well as difficulty to monitor their response, are major limitations to their use.
Pediatric regional anesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain, and is an essential part of modern anesthetic practice. Neuraxial analgesia for pediatric patients is a mode of pain control that gained popularity in the last few decades as it decreases opioid exposure, shortens recovery room time & hospital stay. Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. However, its major side effect is urinary retention and excessive motor block.
Considerable progress has been made in the practice of PRA over the past few years including incorporation of ultrasound guidance, with promising novel regional anesthesia techniques, especially the anterolateral and the posterolateral trunk blocks.
In this study, the investigators will compare the ultrasound guided quadratus lumborum block (QLB) with erector spinae plane block (ESPB), regarding the duration and quality of postoperative analgesia in pediatric patients undergoing unilateral open renal surgeries under general anesthesia. The study hypothesis is that QLB can provide a more superior postoperative pain relief to ESPB in children undergoing open renal surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Acute
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erector spinae plane block (ESPB) group
Arm Type
Active Comparator
Arm Description
30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
Arm Title
Quadratus lumborum block (QLB) group
Arm Type
Active Comparator
Arm Description
30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Erector Spinae Plane Block
Intervention Description
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane deep to erector spinae muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline and observing the fluid lifting the erector spinae muscle off the transverse process (hydrodissection). The ultrasound probe will be placed 2-3 cm lateral to the spinous process on a parasagittal plane, to visualize the erector spinae muscle and transverse process, directing the needle craniocaudally using the in-plane technique. The spread of the injectate will be observed to distribute within this plane.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Quadratus Lumborum Block
Intervention Description
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane between the quadratus lumborum and psoas major muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline (hydrodissection). The ultrasound probe will be placed 2-3 cm lateral to the L2 spinous process on an axial plane, to visualize the transverse process with psoas major muscle anterior, quadratus lumborum muscle lateral and erector spinae muscle posterior to it. The needle is inserted from the medial side of the probe and advanced laterally using the in-plane technique. The spread of the injectate will be observed to distribute within the target plane.
Intervention Type
Device
Intervention Name(s)
Ultrasound Machine
Intervention Description
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
Intervention Type
Device
Intervention Name(s)
Echogenic needle
Intervention Description
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
Intervention Type
Drug
Intervention Name(s)
Pethidine
Intervention Description
Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6. Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
Primary Outcome Measure Information:
Title
Time to first postoperative rescue analgesia
Description
Time in minutes when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score exceeds 6 for the first time. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Total opioid analgesic consumption in the first 12 hours postoperative period
Description
when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score ˃ 6 in the first 12 hours postoperatively. Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
Time Frame
from time of patient transfer to the PACU, till 12 hours postoperatively
Title
Intraoperative mean arterial blood pressure
Description
measured from induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
Time Frame
During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Title
Intraoperative heart rate
Description
measured before and after induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins. after
Time Frame
During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Title
Postoperative pain score
Description
measured at time of patient transfer to the PACU, 15, 30 mins, 1 ,2 , 4 ,6 ,12 hours after surgery
Time Frame
from time of patient transfer to the PACU, till 12 hours postoperatively
Title
Block performance time
Description
Time to perform ultrasound guided nerve block
Time Frame
Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
Other Pre-specified Outcome Measures:
Title
Indirect signs of local anesthetic toxicity
Description
intraoperative arrhythmias and delayed awakening
Time Frame
from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American society of anesthesiologists (ASA) class I and II
Children undergoing unilateral open renal surgeries
Exclusion Criteria:
Parents refusal for the block
Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%)
Skin lesion, wounds or infection at the puncture site.
Known allergy to local anesthetic drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kareem MA Nawwar, M.D.
Phone
+201003878369
Email
drknawwar@cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevine M Gouda
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sherif M Soaida
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ismail S Hammad
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed T Bahnaswy
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children
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