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NCT Number: NCT07801365

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Scheduled for elective surgery
  • Written informed consent obtained from a parent or legal guardian

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Total rescue analgesic consumption during the first 24 postoperative hours

    Time frame: During the first 24 hours after surgery

    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.

  2. Intraoperative remifentanyl consumption

    Time frame: During the surgery

    The cumulative dose of remifentanyl administered during the intraoperative period.

Study contacts

Contact information is provided by the study sponsor or research team.

Aslı Dönmez

CONTACT

[email protected]

00905322256473

Elif Şule Özdemir Sezgi

CONTACT

[email protected]

00905059209638

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Postoperative Analgesic Efficacy of Combined Popliteal and Adductor Canal Blocks in Children With Cerebral Palsy Undergoing Lower Extremity Surgery: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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