An interventional study of Adductor Canal Block + Popliteal Sciatic Nerve Block Group and Control Group in Cerebral Palsy and Postoperative Pain, sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Diskapi Yildirim Beyazit Education and Research Hospital · Not applicable, Interventional, and Treatment
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 50 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Diskapi Yildirim Beyazit Education and Research Hospital is the lead sponsor of 71 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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).
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.
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
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
Intraoperative remifentanyl consumption
The cumulative dose of remifentanyl administered during the intraoperative period.
Time frame: During the surgery
Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 11 months after the start.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 11 months is close to that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Diskapi Yildirim Beyazit Education and Research Hospital