The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Phase 4RecruitingNCT05746143

University of Southern California140 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

140

Conditions

Spine Fusion Lumbar Spine Degeneration Pain, Postoperative Lumbar Spine Spondylosis

Interventions

Zolpidem Tartrate 10 mgDRUG

two days preoperatively and five days postoperatively

PlaceboDRUG

two days preoperatively and five days postoperatively

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Keck Medical Center of USC

Los Angeles, California, United States

RECRUITING

Outcomes

Primary Outcomes

Visual analog scale (VAS)

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 Outcomes

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)

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

Morphine Equivalents

values that represent the potency of an opioid dose relative to morphine

Time frame: Postoperative day one, two, three, four, five, and two weeks

Quality of Recovery - 40 (QoR-40) questionnaire

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

Epworth Sleepiness Score (ESS)

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

Pain Catastrophizing Scale (PCS)

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

Hospital Length of Stay

Time frame: Postoperative two-weeks

Central Contacts

Pui Yan, MS

CONTACT

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

Data from ClinicalTrials.gov

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