Postoperative Dexamethasone for Scoliosis
Recruiting in Palo Alto (17 mi)
Overseen byNicholas Fletcher, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Emory University
Disqualifiers: Congenital scoliosis, Pregnant, Prisoners, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The objective of this study is to perform a prospective, randomized controlled trial investigating the clinical usage of perioperative dexamethasone usage on APR activation, postoperative morphine usage, postoperative nausea, and hospital length of stay.
There will be a control control and a Dexamethasone cohort. Participants will be randomized into one of the two cohorts. Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional doses administered at 8-hour intervals following surgery for a total of 4 doses. All study activities will tale place at Egleston during the patient's planned inpatient stay for their posterior spinal fusion.
This project has the potential to validate the utility of dexamethasone as a way to optimize postoperative care following PSF for AIS by minimizing the need for opioid medications and enhancing mobility and recovery.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Dexamethasone for postoperative recovery in scoliosis surgery?
Research suggests that using dexamethasone after spinal surgery can help patients recover faster and manage pain better, as seen in other orthopedic surgeries, without increasing wound-healing problems.
12345Is dexamethasone safe for use after scoliosis surgery?
The use of dexamethasone after scoliosis surgery is considered based on its benefits in other orthopedic surgeries, such as faster recovery and better pain control, without increasing wound-healing problems.
24567How does the drug dexamethasone differ from standard treatments for scoliosis surgery?
Dexamethasone is unique in scoliosis surgery because it is used postoperatively to potentially reduce opioid use and improve recovery without increasing wound-healing problems, unlike standard treatments that may not include steroids due to concerns about wound complications.
2891011Eligibility Criteria
This trial is for young people aged 10-18 with a type of scoliosis called AIS, who are having spine surgery (PSF) by Dr. Fletcher at Children's Healthcare of Atlanta Egleston. It's not for those with other types of scoliosis, pregnant women, adults over 18, prisoners, or anyone with systemic fungal infections.Inclusion Criteria
I am 10-18 years old, have AIS, and am getting a PSF by Dr. Fletcher at Egleston.
Exclusion Criteria
Prisoners
I have a fungal infection in my body.
Pregnant women
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Treatment
Participants undergo posterior spinal fusion surgery and receive dexamethasone or standard care
Inpatient stay (up to 48 hours)
In-hospital stay
Follow-up
Participants are monitored for changes in interleukin-6, C-reactive protein, and total morphine usage
48 hours post-surgery
Daily monitoring during hospital stay
Participant Groups
The study compares standard care to an enhanced dexamethasone treatment after spine surgery in adolescents. The control group gets one dose during surgery; the test group receives additional doses every 8 hours post-surgery to see if it helps reduce pain and nausea and shortens hospital stays.
2Treatment groups
Experimental Treatment
Active Control
Group I: DexamethasoneExperimental Treatment1 Intervention
Patients will be screened for participation following indication for surgery by the treating surgeon and/or research assistant. Patients who elect to participate will then be randomized into either the dexamethasone or control groups.
Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional (8mg doses) administered at 8-hour intervals following surgery for a total of 4 doses.
Group II: Standard of Care: ControlActive Control1 Intervention
Patients will be screened for participation following indication for surgery by the treating surgeon and/or research assistant. Patients who elect to participate will then be randomized into either the dexamethasone or control groups.
Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. No sham medication will be utilized for control subjects.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children Healthcare of AtlantaAtlanta, GA
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Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
References
Reducing Postoperative Length of Stay for Idiopathic Scoliosis Patients using Quality Improvement Methodology. [2023]Approximately 1%-3% of the US population is diagnosed with scoliosis. In addition, 80% of those diagnosed have idiopathic scoliosis, with about 10% requiring surgical intervention. This Quality Improvement initiative aimed to reduce the length of stay (LOS) after posterior spinal fusion for these patients. According to the Pediatric Health Information System, our institution had a poorer performance, with an actual LOS greater than or equal to the expected LOS compared with peer institutions.
Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. [2021]Surgeons have hesitated to use steroids in patients undergoing posterior spinal fusion because of the risk of wound complications. The literature has supported the use of postoperative steroids in other areas of orthopaedics on the basis of more rapid recovery and improved postoperative pain control. We hypothesized that a short course of postoperative dexamethasone following posterior spinal fusion for the treatment of adolescent idiopathic scoliosis (AIS) would decrease opioid usage without increasing wound-healing problems.
Lacking Benefit of Intraoperative High-Dose Dexamethasone in Instrumented Surgery for Cervical Spondylotic Myelopathy. [2018]Our objective was to investigate the effect of intraoperative dexamethasone administration on wound healing, complications, and clinical outcome in patients with posterior surgery for cervical spondylotic myelopathy (CSM).
Inpatient complications, mortality, and discharge disposition after surgical correction of idiopathic scoliosis: a national perspective. [2008]Information about complications and mortality after surgery for correction of idiopathic scoliosis has been largely derived from single-institution series. Regional or national studies have been lacking.
Trends and Outcomes in Pediatric Patients Undergoing Scoliosis Repair: A Population-Based Study. [2021]Although surgery represents the only definitive treatment for congenital scoliosis, comprehensive information regarding trends in perioperative complications, particularly in the pediatric setting, is lacking. We sought to identify trends in and factors associated with perioperative complications following pediatric scoliosis surgery.
Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. [2021]In spinal deformity surgery, techniques and implants must be assessed for their safety and efficacy. Regulatory bodies, third-party payors, and patients will increasingly scrutinize treatment methods based on the frequency of adverse events. We therefore developed a classification of adverse hardware-related events using plain radiographic criteria. We analyzed the adverse events in 466 patients surgically treated for adolescent idiopathic scoliosis for a Type 1 (Lenke et al.) curve. We used plain radiographic films to define complications as either serious radiographic adverse events or radiographic adverse events in four technique groups: posterior spinal fusion with hooks and/or hybrid systems, posterior spinal fusion using mostly pedicle screws, open anterior spinal fusion, and thoracoscopic anterior spinal fusion. We defined serious radiographic adverse events as those requiring subsequent surgery. The minimum followup was 2 years. We found a reoperation rate ranging from 4.5% (open anterior spinal fusion) to 8.8% (posterior spinal fusion with hooks); we found no difference in the incidence of serious radiographic adverse events between surgical techniques. Among serious radiographic adverse events, the most common problems were revision for lumbar progression, rod breakage, and proximal screw pullout in the anterior spinal fusions and instrumentation removal for pain and infection in the posterior spinal fusions. We propose a new radiographic system of adverse hardware-related events for patients with Type 1 adolescent idiopathic scoliosis.
Complications following surgery for adolescent idiopathic scoliosis over a 13-year period. [2020]The purpose of this study was to evaluate the incidence and analyze the trends of surgeon-reported complications following surgery for adolescent idiopathic scoliosis (AIS) over a 13-year period from the Scoliosis Research Society (SRS) Morbidity and Mortality database.
The safety of perioperative dexamethasone with antiemetic dosage in surgical patients with diabetes mellitus: a systematic review and meta-analysis. [2023]Dexamethasone is commonly used for antiemesis in surgical patients. It has been confirmed that long-term steroid use increases blood glucose level in both diabetic and non-diabetic patients, it is unclear how a single dose of intravenous dexamethasone used pre/intraoperatively for postoperative nausea and vomiting (PONV) prophylaxis would influence the blood glucose and wound healing in diabetic patients.
Effects of Intraoperative Dexamethasone Administration in Adult Diabetic Burn Patients. [2020]The steroid dexamethasone is used intraoperatively to prevent postoperative nausea. Studies of intraoperative steroid use in diabetic patients have shown conflicting effects on blood glucose and complications, and their use has not yet been studied in the burn population. A review of adult diabetic acute burn patients undergoing surgery at a verified burn center from 2012 to 2017 was conducted. Statistical analysis compared those who did and did not receive an intraoperative steroid. A total of 74 patients who underwent 121 operations were identified; steroid was administered in 14.0% of cases. There were no statistically significant differences in preoperative glucose, insulin requirements, TBSA, or hemoglobin A1C. Postoperatively, the steroid group had a 16.7 mg/dl (SD = 11.1) increase in blood glucose (P = .042) and 53.5 unit/24 hour (SD = 28.4) increase in insulin requirement (P = .019), compared with no change in controls. The complication rate in the steroid group was 52.9% compared with 20.1% in controls (P = .003); partial graft loss was the most common complication. Diabetic burn patients who receive intraoperative steroid have increased postoperative blood glucose levels, insulin requirements, and complication rates compared with patients who do not receive steroids. Discussion is warranted to avoid intraoperative steroid in this population.
Effects of prophylactic dexamethasone on postoperative nausea and vomiting in scoliosis correction surgery: a double-blind, randomized, placebo-controlled clinical trial. [2020]Dexamethasone is widely used for postoperative nausea and vomiting (PONV) prophylaxis, but its effect on PONV prevention in paediatric patients is validated only in short minor surgical procedures. In this study, we aimed to determine whether a single dose of dexamethasone reduces PONV in highly invasive surgeries that require opioid-based postoperative analgesia. One hundred adolescents undergoing scoliosis correction surgery were randomized to receive intravenous dexamethasone 0.15 mg/kg (dexamethasone group) or saline (control group) at induction of anaesthesia. The primary outcome was the incidence of PONV in the 72 h postoperatively. Data for 98 patients were available for analysis. The 72-h incidence of PONV was significantly lower in the dexamethasone group than in the control group (62.5% vs 84.0%; RR 0.74, 95% CI 0.58-0.96, P = 0.02). During the first and second 24-h postoperative intervals, fewer patients in the dexamethasone group received rescue antiemetics. Visual analogue scale scores for nausea and pain were lower in the dexamethasone group than in the control group during the first 24 h postoperatively. Dexamethasone did not increase the number of adverse events. The results of this study showed that a single dose of dexamethasone was effective for reducing PONV after paediatric scoliosis correction surgery.
Adverse side-effects of dexamethasone in surgical patients - an abridged Cochrane systematic review. [2019]In the peri-operative period, dexamethasone is widely and effectively used for prophylaxis of postoperative nausea and vomiting. The objective of this meta-analysis was to assess the adverse effects of an incidental steroid load of dexamethasone in adult surgical patients. We searched in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and the Web of Science for randomised controlled trials comparing an incidental steroid load of dexamethasone with a control intervention in adult patients undergoing surgery. Two review authors independently screened studies for eligibility, extracted data and assessed all included studies for bias. Our primary outcomes were postoperative systemic or wound infection, delayed wound healing and glycaemic response within 24 h. We included 37 studies in this meta-analysis. The pooled results found no evidence that dexamethasone increased the risk of a postoperative wound infection, Peto OR (95%CI) 1.01 (0.80-1.27); 4603 participants, 26 studies; I² = 32%; moderate-quality evidence. Whether dexamethasone influenced wound healing was unclear due to the large confidence intervals, Peto OR (95%CI) 0.99 (0.28-3.43); 1072 participants, 8 studies; I² = 0%; low-quality evidence. Dexamethasone produced a mild increase in glucose levels among participants without diabetes during the first 12 h after surgery, mean difference (95%CI) 0.7 mmol.l-1 (0.3-1.2) 10 studies; 595 participants; I² = 50%; low-quality evidence. This article is an abridged version of a Cochrane Review.