Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery

Phase 2TerminatedNCT02276911

St. Joseph's Hospital and Medical Center, Phoenix6 enrolled

Overview

A prospective, randomized, placebo controlled, double-blinded study at a single institution.

Pain medicine literature and the principal investigator's anecdotal experience in posterior cervical and lumbar instrumented spine surgery suggest that pre-incisional IV ibuprofen significantly reduces postoperative pain without increasing surgical complications or fusion rate, which leads to earlier ambulation, less dependence on narcotic medications, shorter hospital stays, and earlier return to work. The purpose of this study is to assess if these anecdotal findings hold true in a randomized clinical trial of patients with cervical or lumbar spondylosis, who are undergoing decompression and instrumented fusion of the spine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cervical Spondylosis Lumbar Spondylosis

Interventions

IbuprofenDRUG

normal salineOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients older than 18 years of age * Able to give consent * Diagnosed with spondylosis, stenosis, and/or instability of the cervical spine * Diagnosed with spondylosis, stenosis, and/or instability of the lumbar spine * Require a posterior decompression with internal fixation * Likely to complete the trial Exclusion Criteria: * Patients with previous surgery at the treated spine segment * Women who are pregnant or plan to become pregnant during the study period Renal/liver disease * Anemia; coagulopathy * Thrombocytopenia (\<30,000) * Coronary artery disease * Previous coronary artery bypass graft (CABG) * Patients taking Coumadin, Plavix, Lithium, or ACE-inhibitors plus Lasix; non-steroidal anti-inflammatory drug (NSAID) hypersensitivity * Gastric ulcers * Recent stroke * Traumatic brain injury, or intracranial surgery

Locations (1)

SJHMC/Barrow Neurosurgical Associates

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Change in pain level

Visual Analog Scale (VAS) scores at rest and with movement, Macqill Pain Questionnaire scores, and total morphine and morphine equivalents used during hospital admission.

Time frame: pre-operative, 1-3 weeks post-operative, 6 months post-operative

Change in overall health/function

SF-36 scores, total length of hospital stay, time to ambulation, and time to return to work.

Time frame: pre-operative, 1-3 weeks post-operative, 6 months post-operative

Fusion rates

Assessed by plain x-rays or CT scans.

Time frame: 6 month post-operative

Data from ClinicalTrials.gov

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