Postoperative Pain Management in Cerebral Palsy - Comparative Observational Study"

NCT05252650 | Unknown

• 1 other identifier: biruni cp
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• pain score

  pain score with r-FLACC

  6 month

Study Arms (2)

regional block

epidural / peripheral nerve block

Behavioral: pain

intravenous

intravenous analgesia

Behavioral: pain

Interventions

pain BEHAVIORAL

postoperative pain

intravenous; regional block

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Ilke Kupeli

Istanbul, 34250, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 21299684 RESULT

• 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: 10.1007/s00540-017-2318-2. Epub 2017 Feb 14.

  PMID: 28197774 RESULT

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

  RESULT

• 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.

  PMID: 29911640 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

ilke kupeli

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: February 23, 2022
• Study Start: February 15, 2022
• Primary Completion: July 28, 2022
• Study Completion: August 5, 2022
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

TU (1)