The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746143
• Other study ID #: HS-22-00529
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: University of Southern California
• Contact: Pui Yan, MS
• Phone: 323-442-6984
• Email: puiyan[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Spine Degeneration
• Lumbar Spine Spondylosis
• Pain, Postoperative
• Spine Fusion
• Spondylosis

Intervention

Drug:
• Zolpidem Tartrate 10 mg
two days preoperatively and five days postoperatively
• Placebo
two days preoperatively and five days postoperatively

Locations

Country	Name	City	State
United States	Keck Medical Center of USC	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Secondary	Morphine Equivalents	values that represent the potency of an opioid dose relative to morphine	Postoperative day one, two, three, four, five, and two weeks
Secondary	Quality of Recovery - 40 (QoR-40) questionnaire	Patient Reported Outcome; score range: 40-200, higher score = greater recovery (better outcome)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Secondary	Epworth Sleepiness Score (ESS)	Patient Reported Outcome; score range: 0-24; higher score = greater daytime sleepiness (worse outcome)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Secondary	Pain Catastrophizing Scale (PCS)	Patient Reported Outcome; scale range: 0-24, higher score = higher pain catastrophizing (worse outcome)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Secondary	Hospital Length of Stay		Postoperative two-weeks
Secondary	Postoperative complications		Postoperative two-years
Secondary	Visual analog scale (VAS)	Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)	preoperative, postoperative day one, three, as well as two weeks and six weeks