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

August 30, 2026 updated by: Elif Sule Ozdemir, Diskapi Yildirim Beyazit Education and Research Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Adductor 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).
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.
Procedure: Control 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 1, 2, 6, 12, and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the first 24 hours after surgery
Intraoperative remifentanyl consumption
Time Frame: During the surgery
The cumulative dose of remifentanyl administered during the intraoperative period.
During the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 14, 2026

Primary Completion (Estimated)

September 14, 2027

Study Completion (Estimated)

September 27, 2027

Study Registration Dates

First Submitted

August 30, 2026

First Submitted That Met QC Criteria

August 30, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 30, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EK-2026-065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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