NCT05929755

Depo-Medrol on Psoas After LLIF

Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hardeep Singh · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine the effects of a corticosteroid administered to the psoas muscle following a transpsoas lateral lumbar interbody fusion (LLIF) on postoperative hip flexor weakness and thigh pain and numbness.

Detailed description

Primary Objective and Outcome Measure: * Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery. Secondary Objectives and Outcome Measures: * Quantify the difference in rates and severity of postoperative hip flexor weakness, and numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection. * Quantity patient reported outcomes measures (PROMs) (EQ5D, ODI, and sciatica Bothersome index between those that did and did not receive a depo-medrol injection. Specifically: * EQ5D: Eur-Quality of Life 5 dimension questionnaire * ODI: Oswestry Disability Index * Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection. Ancillary Objectives and Outcome Measures: * To determine the effect of clinically relevant covariates including sociodemographic and comorbidities on the course of postoperative pain and associated outcome measures and whether the effect of these covariates moderate the effect of postoperative pain. Groups: * Control group (standard care) - 1cc gel foam powder mixed with thrombin * Steroid group (standard care + study intervention) - 1cc gel foam powder mixed with thrombin and 80mg depomedrol

Conditions

• Muscle Weakness
• Pain, Postoperative
• Paresthesia
• Pain, Muscle

Interventions

Type	Name	Description
DRUG	Depo-Medrol	steroid
DRUG	Gel-Flow NT	hemostatic agent

Timeline

• Start date: 2023-05-12
• Primary completion: 2025-08-01
• Completion: 2027-05-01
• First posted: 2023-07-03
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study