Clinical trial NCT05386121: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain, Acute
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to first postoperative rescue analgesia
timeFrame: 12 hours
Secondary outcomes:
measure: Total opioid analgesic consumption in the first 12 hours postoperative period
timeFrame: from time of patient transfer to the PACU, till 12 hours postoperatively
measure: Intraoperative mean arterial blood pressure
timeFrame: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
measure: Intraoperative heart rate
timeFrame: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
measure: Postoperative pain score
timeFrame: from time of patient transfer to the PACU, till 12 hours postoperatively
measure: Block performance time
timeFrame: Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
Other outcomes:
measure: Indirect signs of local anesthetic toxicity
timeFrame: from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively
Locations:
Study officials:
affiliation: Cairo University
name: Nevine M Gouda
role: STUDY_CHAIR
affiliation: Cairo University
name: Sherif M Soaida
role: STUDY_CHAIR
affiliation: Cairo University
name: Ismail S Hammad
role: STUDY_CHAIR
affiliation: Cairo University
name: Ahmed T Bahnaswy
role: PRINCIPAL_INVESTIGATOR
References: