Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2022
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2022
CompletedStudy Start
First participant enrolled
May 20, 2022
CompletedFirst Posted
Study publicly available on registry
May 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedMay 23, 2022
May 1, 2022
3 months
May 8, 2022
May 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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).
12 hours
Secondary Outcomes (5)
Total opioid analgesic consumption in the first 12 hours postoperative period
from time of patient transfer to the PACU, till 12 hours postoperatively
Intraoperative mean arterial blood pressure
During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Intraoperative heart rate
During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Postoperative pain score
from time of patient transfer to the PACU, till 12 hours postoperatively
Block performance time
Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
Other Outcomes (1)
Indirect signs of local anesthetic toxicity
from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively
Study Arms (2)
Erector spinae plane block (ESPB) group
ACTIVE COMPARATOR30 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%
Quadratus lumborum block (QLB) group
ACTIVE COMPARATOR30 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%
Interventions
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.
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.
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
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)
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.
Eligibility Criteria
You may qualify if:
- American society of anesthesiologists (ASA) class I and II
- Children undergoing unilateral open renal surgeries
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nevine M Gouda
Cairo University
- STUDY CHAIR
Sherif M Soaida
Cairo University
- STUDY CHAIR
Ismail S Hammad
Cairo University
- PRINCIPAL INVESTIGATOR
Ahmed T Bahnaswy
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
May 8, 2022
First Posted
May 23, 2022
Study Start
May 20, 2022
Primary Completion
September 1, 2022
Study Completion
September 15, 2022
Last Updated
May 23, 2022
Record last verified: 2022-05