This clinical study will evaluate three commonly used medications that can be added to local anesthetic during a popliteal sciatic nerve block in children undergoing surgery of the lower leg or foot. These medications-dexamethasone, dexmedetomidine, or a combination of both-may help the nerve block last longer and provide better postoperative pain control. All participating children will receive a standard popliteal sciatic nerve block with ropivacaine, a commonly used local anesthetic. They will then be randomly assigned to one of three groups: (1) ropivacaine with dexamethasone, (2) ropivacaine with dexmedetomidine, or (3) ropivacaine with both dexamethasone and dexmedetomidine. Neither the children, parents, nor the clinical staff assessing pain will know which medication was given. The goal of this study is to determine whether the combination of dexamethasone and dexmedetomidine provides longer pain relief and reduces the need for additional pain medication compared with either medication alone. The results may help identify the most effective and safest strategy for improving postoperative comfort in pediatric patients receiving regional anesthesia.
Popliteal sciatic nerve block is frequently used in pediatric anesthesia to provide effective pain control for surgical procedures involving the lower leg, ankle, and foot. Although ropivacaine alone offers good analgesia, its duration is limited, and additional medications (adjuvants) are often added to prolong the effect of the block. Two commonly used adjuvants are dexamethasone, a corticosteroid, and dexmedetomidine, an alpha-2 adrenergic agonist. Each of these medications has been shown to extend the duration of analgesia, but it remains unclear whether combining them provides an additive or potentially synergistic benefit. This randomized, double-blinded, controlled clinical trial will compare three perineural adjuvant strategies: dexamethasone, dexmedetomidine, and their combination. All participants will receive a single-shot popliteal sciatic nerve block with 0.2% ropivacaine. Children will then be randomized into one of three treatment arms: 1. ropivacaine with perineural dexamethasone, 2. ropivacaine with perineural dexmedetomidine, or 3. ropivacaine with a perineural combination of dexamethasone and dexmedetomidine. Pain scores, block duration, opioid use, and recovery parameters will be assessed by trained observers who are blinded to group assignment. The primary aim is to determine whether the combination of dexamethasone and dexmedetomidine leads to superior analgesia compared with either drug alone. Secondary aims include evaluating the time to first rescue analgesia, total postoperative opioid requirements, behavioral pain scores (e.g., FLACC), adverse events, and early functional recovery. This study seeks to provide high-quality evidence to guide the optimal choice of perineural adjuvants in pediatric regional anesthesia and may help establish best-practice recommendations for improving postoperative comfort and safety in children undergoing lower-limb surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Perineural dexamethasone will be administered as an adjuvant to a single-shot popliteal sciatic nerve block. Children will receive 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg dexamethasone, injected under ultrasound guidance using a 22-gauge echogenic needle prior to surgery. The medication will be given as a single perineural dose only. Standard perioperative analgesia will be provided to all participants.
Perineural dexmedetomidine will be administered as an adjuvant to a single-shot popliteal sciatic nerve block. Children will receive 0.3 mL/kg of 0.2% ropivacaine combined with 0.5 µg/kg dexmedetomidine, injected under ultrasound guidance with a 22-gauge echogenic needle prior to surgery. The medication will be administered as a single perineural bolus. Standard perioperative analgesia will be provided to all participants.
Children in this arm will receive a combination of two perineural adjuvants added to a single-shot popliteal sciatic nerve block. The block will include 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg dexamethasone and 0.5 µg/kg dexmedetomidine, administered under ultrasound guidance using a 22-gauge echogenic needle prior to surgery. Both medications will be delivered together as a single perineural bolus. Standard perioperative analgesia will be provided to all participants.
Poznan University of Medical Sciences
Poznan, Poland
RECRUITINGTime to First Rescue Analgesia
Time in hours from completion of the popliteal sciatic nerve block to the first administration of rescue analgesic medication. Rescue analgesia will be provided when the FLACC pain score is ≥ 4, or upon patient/parent request. This measure reflects the duration of effective postoperative analgesia provided by the nerve block.
Time frame: 0-24 hours postoperatively
Total Opioid Consumption
Total amount of opioid rescue medication administered within the first 24 hours after surgery, converted to morphine milligram equivalents (MME). Includes all postoperative rescue doses documented in the anesthesia and nursing records.
Time frame: 0-24 hours postoperatively
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
Time frame: 2 hours postoperatively
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
Time frame: 4 hours postoperatively
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
Time frame: 8 hours postoperatively
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
Time frame: 12 hours postoperatively
FLACC Pain Scores at Rest
Pain intensity measured using the validated FLACC (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Assessments will be performed by trained, blinded observers.
Time frame: 24 hours postoperatively
FLACC Pain Scores During Movement
Pain scores assessed during standardized gentle movement of the operated limb using the FLACC scale (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Movement will be performed by a physiotherapist or trained nurse.
Time frame: 2 hours postoperatively
FLACC Pain Scores During Movement
Pain scores assessed during standardized gentle movement of the operated limb using the FLACC scale (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Movement will be performed by a physiotherapist or trained nurse.
Time frame: 4 hours postoperatively
FLACC Pain Scores During Movement
Pain scores assessed during standardized gentle movement of the operated limb using the FLACC scale (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Movement will be performed by a physiotherapist or trained nurse.
Time frame: 8 hours postoperatively
FLACC Pain Scores During Movement
Pain scores assessed during standardized gentle movement of the operated limb using the FLACC scale (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Movement will be performed by a physiotherapist or trained nurse.
Time frame: 12 hours postoperatively
FLACC Pain Scores During Movement
Pain scores assessed during standardized gentle movement of the operated limb using the FLACC scale (Face, Legs, Activity, Cry, Consolability) pain scale. Scores range from 0 (no pain) to 10 (severe pain). Movement will be performed by a physiotherapist or trained nurse.
Time frame: 24 hours postoperatively
Incidence of Adverse Events
Number of participants experiencing adverse events possibly related to the block or adjuvants, including excessive sedation, bradycardia, hypotension, local anesthetic systemic toxicity, injection-related complications, prolonged motor block, postoperative nausea or vomiting, or unexpected behavioral responses.
Time frame: 0-24 hours postoperatively
Incidence of Persistent Sensory or Motor Deficit (Nerve Injury Screening)
Screening for signs of persistent sensory or motor dysfunction potentially related to the popliteal sciatic nerve block or perineural adjuvants. Follow-up will be conducted through structured telephone interviews with parents or guardians at 1 week and 1 month postoperatively. The assessment will include questions regarding persistent numbness, tingling, altered sensation, weakness of ankle or toe movement, gait abnormalities, or any parental concerns suggestive of nerve dysfunction. If abnormalities are reported, an in-person neurological examination will be offered. This measure assesses the potential impact of perineural dexamethasone, dexmedetomidine, or their combination on nerve integrity.
Time frame: 1 week postoperatively
Incidence of Persistent Sensory or Motor Deficit (Nerve Injury Screening)
Screening for signs of persistent sensory or motor dysfunction potentially related to the popliteal sciatic nerve block or perineural adjuvants. Follow-up will be conducted through structured telephone interviews with parents or guardians at 1 week and 1 month postoperatively. The assessment will include questions regarding persistent numbness, tingling, altered sensation, weakness of ankle or toe movement, gait abnormalities, or any parental concerns suggestive of nerve dysfunction. If abnormalities are reported, an in-person neurological examination will be offered. This measure assesses the potential impact of perineural dexamethasone, dexmedetomidine, or their combination on nerve integrity.
Time frame: 1 month postoperatively
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