NCT05746143

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
57mo left

Started Feb 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Feb 2022Dec 2030

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

7 years

First QC Date

February 7, 2023

Last Update Submit

April 29, 2026

Conditions

Spine FusionLumbar Spine DegenerationPain, PostoperativeLumbar Spine Spondylosis

Keywords

Lumbar Spine FusionZolpidemPostoperative Outcomes

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale (VAS)

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

    Postoperative day five

Secondary Outcomes (8)

  • Oswestry Disability Index (ODI)

    Preoperative, Postoperative day three, five, as well as two weeks and six weeks

  • Morphine Equivalents

    Postoperative day one, two, three, four, five, and two weeks

  • Quality of Recovery - 40 (QoR-40) questionnaire

    Preoperative, Postoperative day three, five, as well as two weeks and six weeks

  • Epworth Sleepiness Score (ESS)

    Preoperative, Postoperative day three, five, as well as two weeks and six weeks

  • Pain Catastrophizing Scale (PCS)

    Preoperative, Postoperative day three, five, as well as two weeks and six weeks

  • +3 more secondary outcomes

Study Arms (2)

Zolpidem

EXPERIMENTAL
Drug: Zolpidem Tartrate 10 mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Zolpidem Tartrate 10 mgDRUG

two days preoperatively and five days postoperatively

Zolpidem
PlaceboDRUG

two days preoperatively and five days postoperatively

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Pui Yan, MS

CONTACT

323-442-6984puiyan@med.usc.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Orthopaedic Surgery

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 27, 2023

Study Start

February 1, 2022

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)