Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Study ID
NCT07801365
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Adductor Canal Block + Popliteal Sciatic Nerve Block Group — PROCEDURE
    Following induction of general anesthesia, participants assigned to the intervention group will receive ultrasound-guided popliteal sciatic nerve block and adductor canal block. Both blocks will be performed using 0.25% bupivacaine, with a total local anesthetic volume of 0.5 mL/kg for the combined blocks (maximum volume 20 ml).
  • Control Group — PROCEDURE
    Participants assigned to the control group will receive intravenous paracetamol at a dose of 15 mg/kg intraoperatively as part of the standard analgesic protocol. No peripheral nerve block will be performed in this group.

Study Details

This prospective, randomized, controlled trial aims to evaluate the postoperative analgesic efficacy of combined ultrasound-guided popliteal sciatic nerve block and adductor canal block in children with cerebral palsy undergoing elective lower extremity surgery. Children aged 3-18 years with American Society of Anesthesiologists (ASA) physical status II-III will be randomized into two groups. Participants in the intervention group will receive combined popliteal sciatic nerve block and adductor canal block in addition to general anesthesia, whereas participants in the control group will receive general anesthesia with intravenous analgesia without peripheral nerve block. Postoperative pain will be assessed using the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) scale at 1, 2, 6, 12, and 24 hours after surgery by an anesthesiologist blinded to group allocation.

Key Dates

First listed
Sep 3, 2026
Start date
Sep 14, 2026
Status verified
Aug 2026
Primary completion
Sep 14, 2027
Completion
Sep 27, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adductor Canal Block + Popliteal Sciatic Nerve Block Group
    Participants assigned to this group will undergo general anesthesia followed by ultrasound-guided combined popliteal sciatic nerve block and adductor canal block. Both blocks will be performed after induction of general anesthesia using 0.25% bupivacaine, with a total local anesthetic volume of 0.5 mL/kg (maximum volume 20 mL). Before the end of surgery, all participants will receive intravenous acetaminophen (paracetamol) at a dose of 15 mg/kg. Postoperative pain will be assessed using the revised Face, Legs, Activity, Cry, and Consolability (r- FLACC) scale at 1, 2, 6, 12, and 24 hours after surgery. If the r- FLACC score is greater than 3, intravenous morphine 25 µg/kg will be administered in the post-anesthesia care unit, or oral ibuprofen 10 mg/kg will be administered in the inpatient ward.
  • Active Comparator: Control Group
    Participants assigned to this group will undergo general anesthesia without peripheral nerve block. Intravenous paracetamol at a dose of 15 mg/kg will be administered intraoperatively as part of the standard analgesic protocol. If the postoperative r- FLACC score is greater than 3, intravenous morphine 25 µg/kg will be administered in the post-anesthesia care unit, or oral ibuprofen 10 mg/kg will be administered in the inpatient ward.

Primary Outcome Measure

Postoperative pain intensity assessed using the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) scale [ Time Frame: At 1, 2, 6, 12, and 24 hours after surgery ]

Central Contacts

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