The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Sponsor

University of Southern California (Other)

Overall Status

Recruiting

CT.gov ID

NCT05746143

Collaborator

(none)

140

Enrollment

Location

Arms

46.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spine Fusion Lumbar Spine Degeneration Pain, Postoperative Lumbar Spine Spondylosis	Drug: Zolpidem Tartrate 10 mg Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zolpidem	Drug: Zolpidem Tartrate 10 mg two days preoperatively and five days postoperatively
Placebo Comparator: Placebo	Drug: Placebo two days preoperatively and five days postoperatively

Arm

Intervention/Treatment

Experimental: Zolpidem

Drug: Zolpidem Tartrate 10 mg

two days preoperatively and five days postoperatively

Placebo Comparator: Placebo

Drug: Placebo

two days preoperatively and five days postoperatively

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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