Chronic Postsurgical Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, Chronic Post Surgical Pain. Basic parameters: 5 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Chronic Postsurgical Pain in Cerebral Palsy
Overview
The study purpose is to document the typical trajectory of perioperative pain experience in Cerebral Palsy (CP) and to identify important predictive factors for the development of chronic postsurgical pain. The main aims of the investigators are to: 1. Quantify the trajectory of pain and opioid use in the context of orthopedic surgery in children with CP. 2. Identify predictors for CPSP in children with CP and develop an applicable risk index. 3. Examine relationships between perioperative pain severity and functional/mobility outcomes achieved by orthopedic surgery in children with CP. Participants will complete: 1. Questionnaires/Surveys via email and text message 2. In-person Sensory Tests 3. In-person Gait and Motion Analysis
Primary outcome measures
- Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative [Time frame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative]
Secondary outcome measures (4)
- Dalhousie Pain Interview (DPI) [Time frame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative]
- Numeric Rating Scale (NRS) [Time frame: From Post-Operative Day (POD) 3-90]
- SNAKE (Schlaffragebogen für Kinder mit Neurologischen und Anderen Komplexen Erkrankungen)Sleep Questionnaire [Time frame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative]
- Gait Outcomes Assessment List (GOAL) [Time frame: Any time preoperative and 12 months postoperative]
Eligibility criteria
Inclusion criteria
- CP diagnosis
- Have a scheduled lower extremity or spine orthopedic surgery
Exclusion criteria
- Non-English speaking and reading parent/guardian
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Nemour's Children's Hospital — Wilmington
- Gillette Children's Specialty Healthcare — Saint Paul
Publications
- Barney CC, Stibb SM, Merbler AM, Summers RLS, Deshpande S, Krach LE, Symons FJ. Psychometric properties of the brief pain inventory modified for proxy report of pain interference in children with cerebral palsy with and without cognitive impairment. Pain Rep. 2018 Jul 17;3(4):e666. doi: 10.1097/PR9.0000000000000666. eCollection 2018 Jul-Aug. PMID 30123858
- Chidambaran V, Ding L, Moore DL, Spruance K, Cudilo EM, Pilipenko V, Hossain M, Sturm P, Kashikar-Zuck S, Martin LJ, Sadhasivam S. Predicting the pain continuum after adolescent idiopathic scoliosis surgery: A prospective cohort study. Eur J Pain. 2017 Aug;21(7):1252-1265. doi: 10.1002/ejp.1025. Epub 2017 Mar 27. PMID 28346762
- Delafontaine A, Presedo A, Mohamed D, Lopes D, Wood C, Alberti C. Equimolar mixture of nitroux oxyde and oxygen during post-operative physiotherapy in patients with cerebral palsy: A randomized, double-blind, placebo-controlled study. Eur J Pain. 2017 Nov;21(10):1657-1667. doi: 10.1002/ejp.1071. Epub 2017 Jul 20. PMID 28726270
- Boyer ER, Stout JL, Laine JC, Gutknecht SM, Araujo de Oliveira LH, Munger ME, Schwartz MH, Novacheck TF. Long-Term Outcomes of Distal Femoral Extension Osteotomy and Patellar Tendon Advancement in Individuals with Cerebral Palsy. J Bone Joint Surg Am. 2018 Jan 3;100(1):31-41. doi: 10.2106/JBJS.17.00480. PMID 29298258
- Dreher T, Thomason P, Svehlik M, Doderlein L, Wolf SI, Putz C, Uehlein O, Chia K, Steinwender G, Sangeux M, Graham HK. Long-term development of gait after multilevel surgery in children with cerebral palsy: a multicentre cohort study. Dev Med Child Neurol. 2018 Jan;60(1):88-93. doi: 10.1111/dmcn.13618. Epub 2017 Nov 24. PMID 29171016
- Munger ME, Aldahondo N, Krach LE, Novacheck TF, Schwartz MH. Long-term outcomes after selective dorsal rhizotomy: a retrospective matched cohort study. Dev Med Child Neurol. 2017 Nov;59(11):1196-1203. doi: 10.1111/dmcn.13500. Epub 2017 Aug 8. PMID 28786493
- Thomason P, Baker R, Dodd K, Taylor N, Selber P, Wolfe R, Graham HK. Single-event multilevel surgery in children with spastic diplegia: a pilot randomized controlled trial. J Bone Joint Surg Am. 2011 Mar 2;93(5):451-60. doi: 10.2106/JBJS.J.00410. PMID 21368077
- Wilson NC, Chong J, Mackey AH, Stott NS. Reported outcomes of lower limb orthopaedic surgery in children and adolescents with cerebral palsy: a mapping review. Dev Med Child Neurol. 2014 Sep;56(9):808-14. doi: 10.1111/dmcn.12431. Epub 2014 Mar 28. PMID 24673603
Identifiers
NCT: NCT05764681 · STUDY00014668 · 1R01HD108406-01A1