PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-16
SponsorPoznan University of Medical Sciences
About this trial
This randomized controlled trial (RCT) compares the analgesic effectiveness of two regional anesthesia techniques-Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve Block (LFCB) versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB)-in pediatric patients undergoing hip surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients aged between 2 and 16 years.
Scheduled for elective orthopedic hip surgery, including: Osteotomies and Hip reconstruction surgeries
ASA (American Society of Anesthesiologists) physical status classification: I-III.
Written informed consent obtained from the patient's legal guardian(s).
Disqualifiers
Known allergy or hypersensitivity to any of the study medications
Presence of infection or inflammation at the intended injection site(s) of regional anesthesia.
Coagulopathy or bleeding disorders (including patients on anticoagulant therapy) that contraindicate nerve blocks.
Neurological disorders or peripheral neuropathies that could influence sensory or motor assessment of the lower limbs.
Trial design
Design model
Parallel
Treatments tested in this trial
Ropivacaine 0.2% for PENG Block
DrugU-S guided PENG (0.4 mL/kg) with 0.2% ropivacaine
Ropivacaine 0.2% for LFCB
DrugLFCB (0.1 mL/kg) with 0.2% ropivacaine
Ropivacaine 0.2% for L-ESPB
DrugLumbar ESPB (0.25ml/kg) with 0.2% ropivacaine
Ropivacaine 0.2% for S-ESPB
DrugSacral ESPB (0.25ml/kg) with 0.2% ropivacaine
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PENG + LFCBActive comparator 2 interventions
Group B: L-ESPB + S-ESPBActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Total Opioid Consumption
Total opiate consumption after surgery
Time frame
48 hours after surgerySecondary outcomes
1
Time to first rescue opioid analgesia
Time after surgery when the patient needs opiate for the first time
Time frame
48 hours after surgery2
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Time frame
4 hours after surgery3
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Time frame
8 hours after surgery4
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Time frame
12 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov