Peri-operative Use of a Pain Injection in Pediatric Patients With Cerebral Palsy

NCT04074265 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-001423
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

Brief Summary

Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. Adequate pain control after surgery is pivotal for these patients in order to prevent negative physiologic and psychologic complications and to improve surgical outcomes. There is an ongoing shift away from the use of opioids in the post-operative setting due to both their negative side effects and their high potential for dependence and abuse. A variety of new techniques of multimodal pain management have been developed and utilized in elective orthopaedic procedures. Injection of local anesthetics is becoming a widely popular technique utilized in adult arthroplasty. This technique blocks pain directly at the site of injection, and therefore can improve post-operative pain while minimizing side effects. Evidence has demonstrated this technique to be both safe and effective, resulting in reduced opioid consumption post-operatively. However, this technique has not been studied for use in pediatric patients, a population in which reduced narcotic use is equally, if not more important than in adult patients. This study is a prospective, randomized controlled trial with 2 parallel arms. The goal of this study is to assess the efficacy of a surgical-site pain injection administered in pediatric patients with cerebral palsy undergoing major hip surgery. Patients who are scheduled to undergo surgery will be randomized to either intervention (injection of a pain cocktail) or placebo (injection of normal saline). The pain cocktail includes three medications: ropivacaine (a local anesthetic), ketorolac (an anti-inflammatory medication), and epinephrine (a medication to constrict blood vessels and increase the duration of action of any co-administered medications). A surgeon who is blinded to treatment group will administer the injection at the end of the procedure, prior to the patient waking from anesthesia. The injection is in addition to our typical multi-modal pain control protocol, which includes epidural anesthesia, acetaminophen, anti-inflammatories, oral narcotics and anti-spasmodic agents. Patients will then be monitored post-operatively and pain medication consumption (both while in the hospital post-operatively and for the first two weeks following discharge), patient-reported and/or nurse-recorded pain scores, length of hospital stay, and adverse effects will be recorded. At the first post-operative visit, patients' parents will be asked to complete a survey designed to assess parent satisfaction with their child's pain management after surgery. Patients, parents, and surgeons will be blinded to treatment group allocation. Data will be collected while the patient is in the hospital, after surgery (average duration 3-4 days), and at the first post-operative visit two to three weeks after surgery.

Conditions

Cerebral Palsy; Hip Dysplasia; Pain, Postoperative

Keywords

cerebral palsy; randomized controlled trial; pediatric; pain management; perioperative medicine

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Average post-operative opioid consumption, measured in morphine equivalents per kilogram

  During initial post-operative hospitalization (estimated 3-4 days)

Secondary Outcomes (3)

• Hospital Length of Stay

  7 days

• Post-operative Pain Scores

  7 days

• Parent Satisfaction

  3 weeks

Study Arms (2)

Pain injection

ACTIVE COMPARATOR

This group will be injected with a cocktail totaling 40mL (20mL on each side) that will be composed of ropivicaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), ketorolac 30mg/mL (0.5mg/kg).

Drug: Ropivacaine injection

Normal saline

PLACEBO COMPARATOR

The control group will receive an injection of 40mL of 0.9% sodium chloride solution.

Drug: normal saline

Interventions

Ropivacaine injection DRUG

Injection containing a mix of the above medications will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).

Also known as: ropivacaine, ketorolac, epinephrine

Pain injection

normal saline DRUG

Injection containing normal saline will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).

Normal saline

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• under 18 years old
• diagnosis of cerebral palsy
• undergoing uni- or bilateral proximal femoral osteotomy

You may not qualify if:

• ongoing preoperative opioid use
• history of allergic reaction to any component of the pain injection

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Northwestern University: collaborator

Study Sites (4)

Orthopaedic Institute for Children

Los Angeles, California, 90007, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UCLA Medical Center, Santa Monica

Santa Monica, California, 90404, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• Allen JD, Casavant MJ, Spiller HA, Chounthirath T, Hodges NL, Smith GA. Prescription Opioid Exposures Among Children and Adolescents in the United States: 2000-2015. Pediatrics. 2017 Apr;139(4):e20163382. doi: 10.1542/peds.2016-3382. Epub 2017 Mar 20.

  PMID: 28320869 BACKGROUND

• Andersen KV, Pfeiffer-Jensen M, Haraldsted V, Soballe K. Reduced hospital stay and narcotic consumption, and improved mobilization with local and intraarticular infiltration after hip arthroplasty: a randomized clinical trial of an intraarticular technique versus epidural infusion in 80 patients. Acta Orthop. 2007 Apr;78(2):180-6. doi: 10.1080/17453670710013654.

  PMID: 17464604 BACKGROUND

• Chaw S, Lo Y, Shariffuddin II, Wong J, Lee J, Leong DW, Ng KW, Chan L. Evaluation of the quality of acute pain management in a pediatric surgical setting: Validation of a parent proxy modified version of the revised American Pain Society Patient Outcome Questionnaire. Paediatr Anaesth. 2019 Jan;29(1):68-76. doi: 10.1111/pan.13528. Epub 2018 Oct 31.

  PMID: 30381868 BACKGROUND

• Harbaugh CM, Lee JS, Hu HM, McCabe SE, Voepel-Lewis T, Englesbe MJ, Brummett CM, Waljee JF. Persistent Opioid Use Among Pediatric Patients After Surgery. Pediatrics. 2018 Jan;141(1):e20172439. doi: 10.1542/peds.2017-2439. Epub 2017 Dec 4.

  PMID: 29203521 BACKGROUND

• Koehler D, Marsh JL, Karam M, Fruehling C, Willey M. Efficacy of Surgical-Site, Multimodal Drug Injection Following Operative Management of Femoral Fractures: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Mar 15;99(6):512-519. doi: 10.2106/JBJS.16.00733.

  PMID: 28291185 BACKGROUND

• Nolan J, Chalkiadis GA, Low J, Olesch CA, Brown TC. Anaesthesia and pain management in cerebral palsy. Anaesthesia. 2000 Jan;55(1):32-41. doi: 10.1046/j.1365-2044.2000.01065.x.

  PMID: 10594431 BACKGROUND

• Troelsen A, Elmengaard B, Soballe K. A new minimally invasive transsartorial approach for periacetabular osteotomy. J Bone Joint Surg Am. 2008 Mar;90(3):493-8. doi: 10.2106/JBJS.F.01399.

  PMID: 18310698 BACKGROUND

• Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173.

  PMID: 16452738 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Hip Dislocation; Pain, Postoperative; Agnosia

Interventions

Ropivacaine; Ketorolac; Epinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Rachel Thompson
• Organization: University of California, Los Angeles

rathompson@mednet.ucla.edu

8472200324

Study Officials

• Rachel M Thompson, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Surgeon, participant, and all nursing staff involved in recording post-operative outcomes will be blinded to treatment group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Center for Cerebral Palsy

Model Details: Patients will be assigned to either treatment/intervention group or placebo. All other aspects of care will be identical between the two groups.

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 30, 2019
• Study Start: December 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: June 10, 2024
• Results First Posted: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)