Postoperative Pain Management in Cerebral Palsy - Comparative Observational Study"

Pain, Postoperative Clinical Trial

Official title:

Postoperative Pain Management in Pediatric Patients With Cerebral Palsy - Comparative Observational Study"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05252650
• Other study ID #: biruni cp
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: August 5, 2022

Study information

• Verified date: February 2022
• Source: Biruni University
• Contact: ilke kupeli
• Phone: +905555485632
• Email: ilkeser2004[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: August 5, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cerebral Palsy
• Pain, Postoperative

Intervention

Behavioral:
• pain
postoperative pain

Locations

Country	Name	City	State
Turkey	Ilke Kupeli	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Evreinov, V. V., & Zhirova, T. A. (2020). Regional anesthetic techniques for hip surgery in children with cerebral palsy. Genij Ortopedii, 26(4), 521-256.

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. — View Citation

Ozkan 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: — View Citation

Pedersen LK, Rahbek O, Nikolajsen L, Møller-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	pain score with r-FLACC	6 month