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The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Primary Purpose

Spine Fusion, Lumbar Spine Degeneration, Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zolpidem Tartrate 10 mg
Placebo
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spine Fusion focused on measuring Lumbar Spine Fusion, Zolpidem, Postoperative Outcomes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Keck Medical Center of USCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zolpidem

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Visual analog scale (VAS)
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)
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
values that represent the potency of an opioid dose relative to morphine
Quality of Recovery - 40 (QoR-40) questionnaire
Patient Reported Outcome; score range: 40-200, higher score = greater recovery (better outcome)
Epworth Sleepiness Score (ESS)
Patient Reported Outcome; score range: 0-24; higher score = greater daytime sleepiness (worse outcome)
Pain Catastrophizing Scale (PCS)
Patient Reported Outcome; scale range: 0-24, higher score = higher pain catastrophizing (worse outcome)
Hospital Length of Stay
Postoperative complications
Visual analog scale (VAS)
Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)

Full Information

First Posted
February 7, 2023
Last Updated
February 22, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT05746143
Brief Title
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
Official Title
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Fusion, Lumbar Spine Degeneration, Pain, Postoperative, Lumbar Spine Spondylosis
Keywords
Lumbar Spine Fusion, Zolpidem, Postoperative Outcomes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zolpidem
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Zolpidem Tartrate 10 mg
Intervention Description
two days preoperatively and five days postoperatively
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
two days preoperatively and five days postoperatively
Primary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)
Time Frame
Postoperative day five
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
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)
Time Frame
Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Title
Morphine Equivalents
Description
values that represent the potency of an opioid dose relative to morphine
Time Frame
Postoperative day one, two, three, four, five, and two weeks
Title
Quality of Recovery - 40 (QoR-40) questionnaire
Description
Patient Reported Outcome; score range: 40-200, higher score = greater recovery (better outcome)
Time Frame
Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Title
Epworth Sleepiness Score (ESS)
Description
Patient Reported Outcome; score range: 0-24; higher score = greater daytime sleepiness (worse outcome)
Time Frame
Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Title
Pain Catastrophizing Scale (PCS)
Description
Patient Reported Outcome; scale range: 0-24, higher score = higher pain catastrophizing (worse outcome)
Time Frame
Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Title
Hospital Length of Stay
Time Frame
Postoperative two-weeks
Title
Postoperative complications
Time Frame
Postoperative two-years
Title
Visual analog scale (VAS)
Description
Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)
Time Frame
preoperative, postoperative day one, three, as well as two weeks and six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pui Yan, MS
Phone
323-442-6984
Email
puiyan@med.usc.edu
Facility Information:
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pui Yan, MS
Phone
323-442-6984
Email
puiyan@med.usc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

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