Cerebral PalsyNCT07801365
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
A study testing Adductor Canal Block + Popliteal Sciatic Nerve Block Group in people with Cerebral Palsy and Postoperative Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy, Postoperative Pain
- What is being tested?
- Adductor Canal Block + Popliteal Sciatic Nerve Block Group
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2026to 27 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara
Elif Şule Özdemir Sezgi, 00905059209638, elifsule-91@hotmail.com
Aslı Dönmez, 00905322256473, aslidonmez@hotmail.com
About this study
Official title: 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.
- Conditions
- Cerebral Palsy, Postoperative Pain
- Being tested
- Adductor Canal Block + Popliteal Sciatic Nerve Block Group, Control Group
- Keywords
- Regional Anesthesia, Peripheral Nerve Block, Popliteal Sciatic Nerve Block, Adductor Canal Block
- Medical subject headings
- Cerebral Palsy, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal Block + Popliteal Sciatic Nerve Block GroupProcedure or 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 GroupProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Block + Popliteal Sciatic Nerve Block Group | Active comparator | 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. Receives: Procedure: Adductor Canal Block + Popliteal Sciatic Nerve Block Group |
| Control Group | Active comparator | 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. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1, 2, 6, 12, and 24 hours after surgery
Secondary outcomes (2)
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.
Measured: During the first 24 hours after surgery
Intraoperative remifentanyl consumption
The cumulative dose of remifentanyl administered during the intraoperative period.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start27 Sep 2026
- Primary completion14 Sep 2027 (estimated)
- Study completion27 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Sule Ozdemir, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801365
- Sponsor's protocol ID
- AEŞH-EK-2026-065
- Status last verified
- Oct 2026
- First submitted
- 30 Aug 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Combined Popliteal and Adductor Canal Blocks in Children With Cerebral Palsy Undergoing Lower Extremity Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07801365
- Acronym / sponsor ID
- AEŞH-EK-2026-065
- Conditions
- Cerebral Palsy, Postoperative Pain
- Keywords
- Regional Anesthesia, Peripheral Nerve Block, Popliteal Sciatic Nerve Block, Adductor Canal Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 27 Sep 2026 (actual)
- Primary completion
- 14 Sep 2027 (estimated)
- Study completion
- 27 Sep 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block + Popliteal Sciatic Nerve Block Group | Active comparator | Procedure: Adductor Canal Block + Popliteal Sciatic Nerve Block GroupParticipants 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. |
| Control Group | Active comparator | Procedure: Control GroupParticipants 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adductor Canal Block + Popliteal Sciatic Nerve Block GroupFollowing 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). | Procedure or surgery | Adductor Canal Block + Popliteal Sciatic Nerve Block Group |
| Control GroupParticipants 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. | Procedure or surgery | Control Group |
Primary outcome
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.
2 secondary outcomes
Total rescue analgesic consumption during the first 24 postoperative hours
Time frame: During the first 24 hours after surgery
Intraoperative remifentanyl consumption
Time frame: During the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor Canal Block + Popliteal Sciatic Nerve Block Group in people with Cerebral Palsy and Postoperative Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Şule Özdemir Sezgi (00905059209638, elifsule-91@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.