Peri-operative Use of a Pain Injection in Pediatric Patients With Cerebral Palsy
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
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.