Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age9-18
SponsorChildren's Hospital Los Angeles
About this trial
The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion.
The main question it aims to answer are:
* What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)? * Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation?
Participants will:
* Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years * Have clinical photos of their incision at 3 months, 1 year, and 2 years
* Their photos will be assessed using the stony book scar evaluation scale * For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand. * Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Prior instrumentation or spine surgery
Conditions associated with increased wound healing issues such as spina bifida
Non AIS or NMS patients
Not undergoing PSF
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone
DrugThree (3) post operative intravenous dexamethasone injections at 8-hour intervals post-operatively. Dosing will be determined as 0.15 mg/kg per dose (WS)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: No Steroid (NS)No intervention 0 interventions
Group B: With Steroid (WS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Length of Stay
Day/hours to discharge from hospital following completion of surgery.
Time frame
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks2
Post Operative Opioid Use
Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg)
Time frame
From date of hospitalization for surgery until date of first discharge, assessed up to two weeksSecondary outcomes
1
Post Operative Ambulation (for ambulatory patients)
Will obtain number of feet ambulated with physical therapy (PT) staff on each post operative day. Will record number of days postoperatively until PT clearance for discharge.
Time frame
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks2
Return of Bowel Function
Will record time to return of bowel sounds as noted by nursing or house staff. Will record time to first bowel movement.
Time frame
From date of hospitalization for surgery until date of first discharge, assessed up to two weeks3
Rate of wound complications requiring intervention
3.1) Additional clinic visits for drainage or wound concerns will be recorded. 3.2) Use of antibiotic for superficial wound issues will be recorded. 3.3) Any additional operative intervention or hospitalization for concern/management of an infection.
Time frame
Less than 90 days from hospitalization4
Scar Appearance
Clinical photos will be obtained and graded with Stony Brook Scar Evaluation Scale. The Stony Brook Scar evaluation scale ranges from a minimum value of 0 (worst) to a maximum value of 5 (best).
Time frame
Immediately from enrollment through study completion, at an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: