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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05058287
Other study ID # 2020-0041
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 5, 2021
Est. completion date December 31, 2024

Study information

Verified date April 2023
Source Hospital for Special Surgery, New York
Contact Rachel Knopp, MPH
Phone (212) 606-1723
Email knoppr@hss.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a randomized controlled trial seeking to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1- to 2- level lumbar laminectomies. Subjects enrolled in this study will be randomized to one of two treatments: either 40 mg Depo-Medrol or 1 mL of sterile normal saline will be applied to the surgical wound prior to closure. The study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures. Subjects will be assessed pre-operatively, while admitted for surgery, and postoperatively daily for two weeks, then again at 1- and 3- months.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Patients scheduled to undergo 1 to 2 level laminectomy - Between the ages of 18-85 Exclusion Criteria: - 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. - Non-English speakers - Patients allergic to Depo-Medrol and/or glucocorticoids, or other steroids

Study Design


Intervention

Drug:
Depo-Medrol 40Mg/Ml Suspension for Injection
40mg Depo-Medrol mixed with hemostatic matrix
Placebo
1 mL of sterile normal saline mixed with hemostatic matrix

Locations

Country Name City State
United States Hospital for Special Surgery New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid use total [Both Groups] Number & dose of opioid taken converted to oral morphine equivalents post-operatively in hospital In hospital, pre-discharge
Primary Opioid use total [Both Groups] Number & dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge Every day for 14 days post- discharge
Primary Opioid consumption [Both Groups] Is participant still taking post-op opioids 6-Week Post-Op
Primary Opioid consumption [Both Groups] Is participant still taking post-op opioids 3-Months Post-Op
Secondary 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 pre-operative
Secondary 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; every day for 14 days post-op
Secondary 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 6-week
Secondary 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 3-month follow up
Secondary Veterans Rand 12-Item Health Survey [Both Groups] Baseline pain as measured through VR-12 pre-operative
Secondary Veterans Rand 12-Item Health Survey [Both Groups] Change in baseline pain as measured through VR-12 2 week post-op
Secondary Veterans Rand 12-Item Health Survey [Both Groups] Change in baseline pain as measured through VR-12 6 week post-op
Secondary Veterans Rand 12-Item Health Survey [Both Groups] Change in baseline pain as measured through VR-12 3 month post-op
Secondary Oswestry Low Back Pain Disability Questionnaire [Both Groups] Baseline pain as measured through ODI pre-operative
Secondary Oswestry Low Back Pain Disability Questionnaire [Both Groups] Change in baseline pain as measured through ODI 2 week
Secondary Oswestry Low Back Pain Disability Questionnaire [Both Groups] Change in baseline pain as measured through ODI 6 week
Secondary Oswestry Low Back Pain Disability Questionnaire [Both Groups] Change in baseline pain as measured through ODI 3 month follow up
Secondary Return to Work [Both Groups] Date participant returned to work 2 week
Secondary Return to Work [Both Groups] Date participant returned to work 6 week
Secondary Return to Work [Both Groups] Date participant returned to work 3 month follow up
Secondary Medical Complications [Both Groups] Any medical complications 2 week
Secondary Medical Complications [Both Groups] Any medical complications 6 week
Secondary Medical Complications [Both Groups] Any medical complications 3 month follow up
Secondary Re-admissions [Both Groups] Any re-admissions 2 Week
Secondary Re-admissions [Both Groups] Any re-admissions 6 Week
Secondary Re-admissions [Both Groups] Any re-admissions 3 Month
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