Health TrialsbyHealthPanel

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

ConditionsOpioid UseLumbar Spinal StenosisPain, PostoperativePain, Back
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHospital for Special Surgery, New York

About this trial

This study seeks to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1-2 level lumbar laminectomy. The study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled to undergo 1 to 2 level laminectomy

Between the ages of 18-85

Disqualifiers

Minimally invasive surgery

Prior daily opioid usage within 6 months.

Use of concomitant procedures such as spinal fusion, revision procedure at the same level.

History of a chronic pain syndrome, uncontrolled diabetes defined as A1C > 6.5, immunocompromised condition such as active cancer treatment, history of transplant, benign prostatic hyperplasia or history of urinary retention, and other conditions which require chronic steroid therapy or immunosuppressants.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Depo-Medrol 40Mg/Ml Suspension for Injection

    Drug

    40mg Depo-Medrol mixed with hemostatic matrix

  • Placebo

    Drug

    1 mL of sterile normal saline mixed with hemostatic matrix

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Group 1: Topical SteroidExperimental treatment 1 intervention
Group B: Group 2: Topical Normal SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Opioid use total [Both Groups]

Number \& dose of opioid taken converted to oral morphine equivalents post-operatively in hospital

Time frame
In hospital, pre-discharge
2

Opioid use total [Both Groups]

Number \& dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge

Time frame
Every day for 14 days post- discharge
3

Opioid consumption [Both Groups]

Is participant still taking post-op opioids

Time frame
6-Week Post-Op
4

Opioid consumption [Both Groups]

Is participant still taking post-op opioids

Time frame
3-Months Post-Op

Secondary outcomes

1

Numeric Rating Pain Scale [Both Groups]

Baseline pain as measured through the NRS 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe

Time frame
pre-operative
2

Numeric Rating Pain Scale [Both Groups]

Change in baseline pain as measured through the NRS Scale: 0-10 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe;

Time frame
every day for 14 days post-op
3

Numeric Rating Pain Scale [Both Groups]

Change in baseline pain as measured through the NRS Scale: 0-10 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe

Time frame
6-week
4

Numeric Rating Pain Scale [Both Groups]

Change in baseline pain as measured through the NRS Scale: 0-10 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe

Time frame
3-month follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital for Special Surgery, New York

Lead sponsor

Source ClinicalTrials.gov
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