Cerebral Palsy, Postoperative Pain
Conditions
Keywords
Regional Anesthesia, Peripheral Nerve Block, Popliteal Sciatic Nerve Block, Adductor Canal Block
Brief summary
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.
Interventions
PROCEDUREAdductor Canal Block + Popliteal Sciatic Nerve Block Group
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).
PROCEDUREControl Group
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.
Sponsors
Diskapi Yildirim Beyazit Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity assessed using the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Total rescue analgesic consumption during the first 24 postoperative hours | 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. |
| Intraoperative remifentanyl consumption | During the surgery | The cumulative dose of remifentanyl administered during the intraoperative period. |
Countries
Turkey (Türkiye)
Contacts
CONTACTElif Şule Özdemir Sezgi
CONTACTAslı Dönmez
Outcome results
None listed