Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Pain, Postoperative Clinical Trial

Official title:

Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058287
• Other study ID #: 2020-0041
• Status: Recruiting
• Phase: Phase 3
• Start date: November 5, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Hospital for Special Surgery, New York
• Contact: Rachel Knopp, MPH
• Phone: (212) 606-1723
• Email: knoppr[@]hss.edu
• Is FDA regulated: No
• 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, 2024
• 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

Related Conditions & MeSH terms

• Back Pain
• Lumbar Spinal Stenosis
• Opioid Use
• Pain, Back
• Pain, Postoperative
• Spinal Stenosis

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