The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Phase 4

Recruiting

• Conditions: Spine Fusion; Lumbar Spine Degeneration; Pain, Postoperative; Lumbar Spine Spondylosis
• Interventions: Drug: Zolpidem Tartrate 10 mg; Drug: Placebo

• Registration Number: NCT05746143
• Lead Sponsor: University of Southern California

Brief Summary

The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.

Detailed Description

Patients who are undergoing one- to three-level spinal fusion for degenerative lumbar disease will be recruited. They will be randomized to either receive zolpidem or placebo two days preoperatively and five days postoperatively.

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-02-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-25
• Primary Completion: 2026-01-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• degenerative lumbar disease
• age of 18-75
• undergoing open primary one- to three-level lumbar fusion

Exclusion Criteria

• currently use a sleep aid nightly
• diagnosed with insomnia or sleep apnea
• history of delirium with opiates or zolpidem
• allergic to opiates or zolpidem
• had previous lumbar spine surgery
• undergoing minimally invasive lumbar fusion,
• undergoing lumbar fusion for fracture, infection, tumor, or an inflammatory spondyloarthropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zolpidem	Zolpidem Tartrate 10 mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS)	Postoperative day five	Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks	Patient reported outcome with regard to low back pain and function; score range: 0-100%, higher scores = higher disability from low back pain (worse outcome)
Morphine Equivalents	Postoperative day one, two, three, four, five, and two weeks	values that represent the potency of an opioid dose relative to morphine
Quality of Recovery - 40 (QoR-40) questionnaire	Preoperative, Postoperative day three, five, as well as two weeks and six weeks	Patient Reported Outcome; score range: 40-200, higher score = greater recovery (better outcome)
Epworth Sleepiness Score (ESS)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks	Patient Reported Outcome; score range: 0-24; higher score = greater daytime sleepiness (worse outcome)
Pain Catastrophizing Scale (PCS)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks	Patient Reported Outcome; scale range: 0-24, higher score = higher pain catastrophizing (worse outcome)
Hospital Length of Stay	Postoperative two-weeks
Postoperative complications	Postoperative two-years
Visual analog scale (VAS)	preoperative, postoperative day one, three, as well as two weeks and six weeks	Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)

Trial Locations

Locations (1)

Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States