Spinal Fusions Steroid Study

Spinal Fusion Clinical Trial

— SFSS  

Official title:

Perioperative IV Steroid Administration Lowers Post-operative Pain Levels and Opioid Use in Pediatric Patients After Posterior Spinal Fusion and Instrumentation for Spine Deformity.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05287035
• Other study ID #: STUDY00002340
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: July 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current efforts to improve pain alleviation focus on non-opioid pharmaceuticals. Intravenous perioperative corticosteroid administration has been suggested as an alternative method for post-operative pain control. The evidence regarding perioperative intravenous corticosteroids to help alleviate post-operative pain is mixed. Some meta-analyses report decreased opioid consumption and decreased pain intensity after a variety of surgical procedures. However, a study of larger orthopedic procedures found no benefit. The catabolic and immunosuppressant effects of corticosteroids also pose issues with wound healing and infection, which can have severe consequences after spine surgery. There is limited data on the effect of perioperative intravenous steroid administration on pain alleviation in children having surgery to address spine deformity. A recent retrospective review demonstrated that perioperative corticosteroid administration was associated with a statistically significant decrease in opioid medication utilization among children and adolescents after spinal deformity surgery. While not increasing the risk of postoperative complications. The investigators hypothesize that the administration of perioperative intravenous dexamethasone will demonstrate a clinically meaningful and statistically significant decrease in postoperative pain intensity, need for opioid medications, time to ambulation, and length of stay in children recovering from surgery for spine deformity.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Meets operative criteria for posterior spinal instrumented fusion for AIS

• Parental consent

Exclusion Criteria:

• Revision procedure

• Other associated conditions which may alter the postoperative course

Related Conditions & MeSH terms

• Spinal Fusion

Intervention

Drug:
• Dexamethasone injection
Dexamethasone will be injected at the dosage recommended by the FDA.

Other:
• Saline injection
Saline will be injected for the placebo arm of the study.

Locations

Country	Name	City	State
United States	Dell Children's Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (14)

Aasboe V, Raeder JC, Groegaard B. Betamethasone reduces postoperative pain and nausea after ambulatory surgery. Anesth Analg. 1998 Aug;87(2):319-23. doi: 10.1097/00000539-199808000-00015. — View Citation

Fletcher ND, Ruska T, Austin TM, Guisse NF, Murphy JS, Bruce RW Jr. Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. J Bone Joint Surg Am. 2020 Oct 21;102(20):1807-1813. doi: 10.2106/JBJS.20.00259. — View Citation

Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014 May;8(3):257-63. doi: 10.1007/s11832-0 — View Citation

Hernandez-Palazon J, Tortosa JA, Martinez-Lage JF, Perez-Flores D. Intravenous administration of propacetamol reduces morphine consumption after spinal fusion surgery. Anesth Analg. 2001 Jun;92(6):1473-6. doi: 10.1097/00000539-200106000-00024. — View Citation

Jirarattanaphochai K, Jung S, Thienthong S, Krisanaprakornkit W, Sumananont C. Peridural methylprednisolone and wound infiltration with bupivacaine for postoperative pain control after posterior lumbar spine surgery: a randomized double-blinded placebo-co — View Citation

Lee CS, Merchant S, Chidambaran V. Postoperative Pain Management in Pediatric Spinal Fusion Surgery for Idiopathic Scoliosis. Paediatr Drugs. 2020 Dec;22(6):575-601. doi: 10.1007/s40272-020-00423-1. Epub 2020 Oct 23. — View Citation

Liu K, Hsu CC, Chia YY. Effect of dexamethasone on postoperative emesis and pain. Br J Anaesth. 1998 Jan;80(1):85-6. doi: 10.1093/bja/80.1.85. — View Citation

Munro HM, Walton SR, Malviya S, Merkel S, Voepel-Lewis T, Loder RT, Farley FA. Low-dose ketorolac improves analgesia and reduces morphine requirements following posterior spinal fusion in adolescents. Can J Anaesth. 2002 May;49(5):461-6. doi: 10.1007/BF03 — View Citation

Pobereskin LH, Sneyd JR. Does wound irrigation with triamcinolone reduce pain after surgery to the lumbar spine? Br J Anaesth. 2000 Jun;84(6):731-4. doi: 10.1093/oxfordjournals.bja.a013583. — View Citation

Romundstad L, Breivik H, Niemi G, Helle A, Stubhaug A. Methylprednisolone intravenously 1 day after surgery has sustained analgesic and opioid-sparing effects. Acta Anaesthesiol Scand. 2004 Nov;48(10):1223-31. doi: 10.1111/j.1399-6576.2004.00480.x. — View Citation

Sharma M, Gupta S, Purohit S, Goyal AK. The Effect of Intravenous Dexamethasone on Intraoperative and Early Postoperative Pain in Lumbar Spine Surgery: A Randomized Double-Blind Placebo-Controlled Study. Anesth Essays Res. 2018 Oct-Dec;12(4):803-808. doi: — View Citation

Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg. 2002 Mar-Apr;10(2):117-29. doi: 10.5435/00124635-200203000-00007. — View Citation

Waldron NH, Jones CA, Gan TJ, Allen TK, Habib AS. Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis. Br J Anaesth. 2013 Feb;110(2):191-200. doi: 10.1093/bja/aes431. Epub 2012 Dec 5. — View Citation

Wittayapairoj A, Wittayapairoj K, Kulawong A, Huntula Y. Effect of intermediate dose dexamethasone on post-operative pain in lumbar spine surgery: A randomized, triple-blind, placebo-controlled trial. Asian J Anesthesiol. 2017 Sep;55(3):73-77. doi: 10.101 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to initial ambulation post-operatively and distance ambulated in first physical therapy session.	The investigators will assess the time to initial ambulation in reference to the surgical stop time recorded in the chart. This time will be calculated in minutes. The total minutes until first ambulation for both arms of the study will be compared. The investigators will assess measure, in feet, the distance patients ambulate during the initial session with physical therapy postoperatively. The distance, in feet, ambulated by patient in each arm of the study will be directly compared.	1 week
Primary	Length of stay in hospital	The investigators will measure the number of days in the hospital from the date of surgery	1 week
Primary	Morphine equivalents use	The investigators will record the amount of morphine equivalents utilized by patients in the post-operative in-hospital period to compare the use of intravenous narcotics in a quantifiable fashion between the two study groups.	1 week
Secondary	Return to emergency department	The investigators will track rates of return to the Emergency Department and/or return for hospital admission after discharge from the hospital. Rates of return to the Emergency Department and/or need for hospital admission will be stratified across 30 day, 90 day, and 365 day intervals after discharge from the hospital. Additionally, data will be collected by the investigators on the cause of return to the Emergency Department and/or return for hospital admission. Examples of cause for return will include: insufficient pain control at home, concerning neurologic findings, inability to tolerate per os nutrition, inability to urinate or defecate, wound dehiscence or drainage, and all other causes.; We will keep track of patients that need to return to the emergency department for any reason.	12 months
Secondary	Return to school	The investigators will determine the length of time it takes a patient to return to school after surgery.	3 months
Secondary	Pain score at discharge	The investigators will record the patient's pain score at regular intervals during hospital admission (typically assessed every 4 hours by the nursing staff) as well as recording pain score at time of discharge from the hospital. Pain scores will be recorded in two fashions. Primarily, a pain score of 0 to 10 will be recorded whereby a patient-reported score of "0" indicates no perceived pain and a score of "10" would indicate severe and intractable pain. Secondarily, as this study involves pediatric patients, the investigators will record pain using the Wong-Baker FACES Pain Rating Scale that similarly uses a scoring system of 0 to 10, but additionally includes illustrations of faces to guide pediatric patients in relating their pain to a numeric score. The Wong-Baker FACES Pain Rating Scale is a validated tool for recording pain levels in pediatric patients and is widely used within the investigators hospital system.	1 week