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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorDiskapi Yildirim Beyazit Education and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric patients aged 3-18 years

Diagnosis of cerebral palsy

Scheduled to undergo lower extremity surgery

American Society of Anesthesiologists (ASA) physical status II-III

Disqualifiers

Age younger than 3 years or older than 18 years

Coagulopathy or any contraindication to peripheral nerve block

Known allergy to local anesthetics

Infection at the planned block site

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adductor Canal Block + Popliteal Sciatic Nerve Block Group

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Adductor Canal Block + Popliteal Sciatic Nerve Block GroupActive comparator 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain intensity assessed using the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) scale

Postoperative pain intensity will be assessed using the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) observational pain scale. The r-FLACC score ranges from 0 to 10, with higher scores indicating greater pain intensity. r-FLACC scores will be recorded at 1, 2, 6, 12, and 24 hours after surgery and compared between the two study groups.

Time frame
At 1, 2, 6, 12, and 24 hours after surgery

Secondary outcomes

1

Total rescue analgesic consumption during the first 24 postoperative hours

The cumulative dose and number of doses of each rescue analgesic administered during the first 24 hours after surgery will be recorded separately. When the r-FLACC score is ≥4, intravenous morphine 25 µg/kg will be administered in the post-anesthesia care unit, whereas oral ibuprofen 10 mg/kg will be administered in the inpatient ward.

Time frame
During the first 24 hours after surgery
2

Intraoperative remifentanyl consumption

The cumulative dose of remifentanyl administered during the intraoperative period.

Time frame
During the surgery

Other outcomes

Sponsors and contacts

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