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Spinal FusionEarly Phase 1SFSSNCT05287035

Spinal Fusions Steroid Study

A Early Phase 1 study testing Dexamethasone injection and Saline injection in people with Spinal Fusion, run by University of Texas at Austin at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Spinal Fusion
What is being tested?
Dexamethasone injection and Saline injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteUnited States
Study dates
1 Jul 2023to 1 Jul 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Meets operative criteria for posterior spinal instrumented fusion for AIS
  • Parental consent

Who cannot join

  • Revision procedure
  • Other associated conditions which may alter the postoperative course

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dell Children's Medical Center

    Austin, Texas, 78731

Other trials in United States

About this study

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.

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.

Conditions
Spinal Fusion
Being tested
Dexamethasone injection, Saline injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone injectionDrug

    Dexamethasone will be injected at the dosage recommended by the FDA.

  • Saline injectionOther

    Saline will be injected for the placebo arm of the study.

Study groups in NCT05287035
Study groupRoleWhat they receive
Steroid injectionActive comparatorDexamethasone will be injected 1 dose intraoperatively, 3 doses post-operatively every 8hrs
Receives: Drug: Dexamethasone injection
Saline solutionPlacebo comparatorSaline will be injected 1 dose intraoperatively, 3 doses post-operatively every 8hrs
Receives: Other: Saline injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 week

  2. Length of stay in hospital

    The investigators will measure the number of days in the hospital from the date of surgery

    Measured: 1 week

  3. 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.

    Measured: 1 week

Secondary outcomes (3)

  1. 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.

    Measured: 12 months

  2. Return to school

    The investigators will determine the length of time it takes a patient to return to school after surgery.

    Measured: 3 months

  3. 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.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start1 Jul 2023
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will be a double blinded (patient, surgeon) prospective randomized controlled trial.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05287035
Sponsor's protocol ID
STUDY00002340
Acronym
SFSS
Status last verified
Aug 2023
First submitted
24 Feb 2022
Last updated
22 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: We plan to publish the results of this study. All protected health information (PHI) will be delinked from the participant and will only be accessed by authorized research personnel. IPD will be destroyed at the end of the study.

Publications

  • 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.

    PubMed 11929206

  • 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.

    PubMed 33086348

  • 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.

    PubMed 10895746

  • 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-controlled trial. Spine (Phila Pa 1976). 2007 Mar 15;32(6):609-16; discussion 617. doi: 10.1097/01.brs.0000257541.91728.a1.

    PubMed 17413463

  • 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: 10.1016/j.aja.2017.08.001. Epub 2017 Sep 18.

    PubMed 28986051

  • 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: 10.4103/aer.AER_115_18.

    PubMed 30662111

  • 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.

    PubMed 11375828

  • 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/s11832-014-0587-y. Epub 2014 Apr 27.

    PubMed 24770995

  • 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/BF03017921.

    PubMed 11983659

  • 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.

    PubMed 33094437

  • 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.

    PubMed 9505784

  • 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.

    PubMed 15504180

  • 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.

    PubMed 9706923

  • 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.

    PubMed 23220857

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Dexamethasone injection and Saline injection in people with Spinal Fusion, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to initial ambulation post-operatively and distance ambulated in first physical therapy session. (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05287035, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.

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