Pain, PostoperativeNCT05252650
Postoperative Pain Management in Cerebral Palsy - Comparative Observational Study"
An observational study of Pain, Postoperative, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
In this study, our aim is to examine orthopedic interventions, anesthesia method, postoperative pain level and management applied to patients with CP in biruni university hospital. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- pain
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 5 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years
- All sexes
- No healthy volunteers
- Child
Study population: 130 patients aged 3-15 years with a diagnosis of cerebral palsy, category 2 according to the Classification of the American Society of Anesthesiology (ASA 2), who underwent soft tissue release for knee or ankle flexion contracture of the lower extremity with palliative or reconstructive hip interventions
Who may be able to join
- Diagnosed with cerebral palsy between the ages of 3-15,
- Category 2 according to the Classification of the American Society of Anesthesiology (ASA 2),
- patients undergoing soft tissue release for knee or ankle flexion contracture of the lower extremity with palliative or reconstructive hip interventions
Who cannot join
- Any child with CP younger than 3 years old and older than 15 years has undergone
- procedures without a specific diagnosis of CP,
- the need for bone surgery,
- requiring both hip, knee and ankle surgery in the same session,
- with autonomic neuropathy,
- Patients with a history of anticholinergic and vasoactive drug use or allergy to amide type local anesthetics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ilke Kupeli
Istanbul, 34250
ilke kupeli, 05555485632, ilkeser2004@gmail.com
About this study
Official title: Postoperative Pain Management in Pediatric Patients With Cerebral Palsy - Comparative Observational Study"
In this study, our aim is to examine orthopedic interventions, anesthesia method, postoperative pain level and management applied to patients with CP in biruni university hospital.
- Conditions
- Pain, Postoperative
- Being tested
- pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
painBehavioural
postoperative pain
| Study group | Role | What they receive |
|---|---|---|
| regional block | epidural / peripheral nerve block Receives: Behavioral: pain | |
| intravenous | intravenous analgesia Receives: Behavioral: pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
pain score with r-FLACC
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start15 Feb 2022 (estimated)
- Primary completion28 Jul 2022 (estimated)
- Study completion5 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252650
- Sponsor's protocol ID
- biruni cp
- Status last verified
- Feb 2022
- First submitted
- 13 Feb 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim SH, Chun DH, Chang CH, Kim TW, Kim YM, Shin YS. Effect of caudal block on sevoflurane requirement for lower limb surgery in children with cerebral palsy. Paediatr Anaesth. 2011 Apr;21(4):394-8. doi: 10.1111/j.1460-9592.2011.03530.x. Epub 2011 Feb 8.
PubMed 21299684Ozkan D, Gonen E, Akkaya T, Bakir M. Popliteal block for lower limb surgery in children with cerebral palsy: effect on sevoflurane consumption and postoperative pain (a randomized, double-blinded, controlled trial). J Anesth. 2017 Jun;31(3):358-364. doi: 10.1007/s00540-017-2318-2. Epub 2017 Feb 14.
PubMed 28197774Evreinov, V. V., & Zhirova, T. A. (2020). Regional anesthetic techniques for hip surgery in children with cerebral palsy. Genij Ortopedii, 26(4), 521-256.
Pedersen LK, Rahbek O, Nikolajsen L, Moller-Madsen B. The revised FLACC score: Reliability and validation for pain assessment in children with cerebral palsy. Scand J Pain. 2015 Oct 1;9(1):57-61. doi: 10.1016/j.sjpain.2015.06.007.
PubMed 29911640
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management in Pediatric Patients With Cerebral Palsy - Comparative Observational Study"
- ClinicalTrials.gov ID
- NCT05252650
- Acronym / sponsor ID
- biruni cp
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (estimated)
- Primary completion
- 28 Jul 2022 (estimated)
- Study completion
- 5 Aug 2022 (estimated)
- First posted
- 23 Feb 2022 (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.
In this study, our aim is to examine orthopedic interventions, anesthesia method, postoperative pain level and management applied to patients with CP in biruni university hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regional block | – | Behavioral: painepidural / peripheral nerve block |
| intravenous | – | Behavioral: painintravenous analgesia |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 130 patients aged 3-15 years with a diagnosis of cerebral palsy, category 2 according to the Classification of the American Society of Anesthesiology (ASA 2), who underwent soft tissue release for knee or ankle flexion contracture of the lower extremity with palliative or reconstructive hip interventions
Key inclusion criteria (3 listed)
- Diagnosed with cerebral palsy between the ages of 3-15,
- Category 2 according to the Classification of the American Society of Anesthesiology (ASA 2),
- patients undergoing soft tissue release for knee or ankle flexion contracture of the lower extremity with palliative or reconstructive hip interventions
Key exclusion criteria (6 listed)
- Any child with CP younger than 3 years old and older than 15 years has undergone
- procedures without a specific diagnosis of CP,
- the need for bone surgery,
- requiring both hip, knee and ankle surgery in the same session,
- with autonomic neuropathy,
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 |
|---|---|---|
| painpostoperative pain | Behavioural | intravenous, regional block |
Primary outcome
pain score
Time frame: 6 month
pain score with r-FLACC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Results publication: PubMed 21299684Kim SH, Chun DH, Chang CH, Kim TW, Kim YM, Shin YS. Effect of caudal block on sevoflurane requirement for lower limb surgery in children with cerebral palsy. Paediatr Anaesth. 2011 Apr;21(4):394-8. doi: 10.1111/j.1460-9592.2011.03530.x. Epub 2011 Feb 8.
- Results publication: PubMed 28197774Ozkan D, Gonen E, Akkaya T, Bakir M. Popliteal block for lower limb surgery in children with cerebral palsy: effect on sevoflurane consumption and postoperative pain (a randomized, double-blinded, controlled trial). J Anesth. 2017 Jun;31(3):358-364. doi: 10.1007/s00540-017-2318-2. Epub 2017 Feb 14.
- Results publicationEvreinov, V. V., & Zhirova, T. A. (2020). Regional anesthetic techniques for hip surgery in children with cerebral palsy. Genij Ortopedii, 26(4), 521-256.
- Results publication: PubMed 29911640Pedersen LK, Rahbek O, Nikolajsen L, Moller-Madsen B. The revised FLACC score: Reliability and validation for pain assessment in children with cerebral palsy. Scand J Pain. 2015 Oct 1;9(1):57-61. doi: 10.1016/j.sjpain.2015.06.007.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Biruni University 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilke kupeli (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252650, which also lists 4 linked publications.
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 23 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.