Hospital for Special Surgery
New York, 10021, United States
Location status: Recruiting
Location contact
Matthew Cunningham, MD, PhD
CONTACT
NCT Number: NCT05058287
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 3
New York, 10021, United States
Location status: Recruiting
Matthew Cunningham, MD, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
40mg Depo-Medrol mixed with hemostatic matrix
1 mL of sterile normal saline mixed with hemostatic matrix
Time frame: In hospital, pre-discharge
Number & dose of opioid taken converted to oral morphine equivalents post-operatively in hospital
Time frame: Every day for 14 days post- discharge
Number & dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge
Time frame: 6-Week Post-Op
Is participant still taking post-op opioids
Time frame: 3-Months Post-Op
Is participant still taking post-op opioids
Time frame: pre-operative
Baseline pain as measured through the NRS 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe
Time frame: every day for 14 days post-op
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
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
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: pre-operative
Baseline pain as measured through VR-12
Time frame: 2 week post-op
Change in baseline pain as measured through VR-12
Time frame: 6 week post-op
Change in baseline pain as measured through VR-12
Time frame: 3 month post-op
Change in baseline pain as measured through VR-12
Time frame: pre-operative
Baseline pain as measured through ODI
Time frame: 2 week
Change in baseline pain as measured through ODI
Time frame: 6 week
Change in baseline pain as measured through ODI
Time frame: 3 month follow up
Change in baseline pain as measured through ODI
Time frame: 2 week
Date participant returned to work
Time frame: 6 week
Date participant returned to work
Time frame: 3 month follow up
Date participant returned to work
Time frame: 2 week
Any medical complications
Time frame: 6 week
Any medical complications
Time frame: 3 month follow up
Any medical complications
Time frame: 2 Week
Any re-admissions
Time frame: 6 Week
Any re-admissions
Time frame: 3 Month
Any re-admissions
Contact information is provided by the study sponsor or research team.
Hospital for Special Surgery, New York
Other
Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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