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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Procedure: Ultrasound-guided Erector Spinae Plane Block; Device: Ultrasound Machine; Device: Echogenic needle; Drug: Fentanyl; Drug: Pethidine; Procedure: Ultrasound-guided Quadratus Lumborum Block

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kareem MA Nawwar, M.D.; Phone Number: +201003878369; Email: drknawwar@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. American society of anesthesiologists (ASA) class I and II
2. Children undergoing unilateral open renal surgeries

Exclusion Criteria:

1. Parents refusal for the block
2. Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%)
3. Skin lesion, wounds or infection at the puncture site.
4. Known allergy to local anesthetic drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector spinae plane block (ESPB) group; 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%	Procedure: Ultrasound-guided Erector Spinae Plane Block; 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.; Device: Ultrasound Machine; Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer; Device: Echogenic needle; A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA); Drug: Fentanyl; 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); Drug: Pethidine; 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.
Active Comparator: Quadratus lumborum block (QLB) group; 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%	Device: Ultrasound Machine; Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer; Device: Echogenic needle; A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA); Drug: Fentanyl; 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); Drug: Pethidine; 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.; Procedure: Ultrasound-guided Quadratus Lumborum Block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	from time of patient transfer to the PACU, till 12 hours postoperatively
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	During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
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	During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
Postoperative pain score	measured at time of patient transfer to the PACU, 15, 30 mins, 1 ,2 , 4 ,6 ,12 hours after surgery	from time of patient transfer to the PACU, till 12 hours postoperatively
Block performance time	Time to perform ultrasound guided nerve block	Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indirect signs of local anesthetic toxicity	intraoperative arrhythmias and delayed awakening	from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 15, 2022

Study Registration Dates

• First Submitted: May 8, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Meperidine
• Other Study ID Numbers: md-13-2022

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