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

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

Study Overview

• Status: Terminated
• Conditions: Cervical Spondylosis; Lumbar Spondylosis
• Intervention / Treatment: Drug: Ibuprofen; Other: normal saline

Detailed Description

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
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • SJHMC/Barrow Neurosurgical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous (IV) ibuprofen; 800mg IV ibuprofen before incision, followed by four total scheduled doses of IV ibuprofen every six hours for 24 hours, in addition to whatever narcotic or other pain control regimens prescribed by the treating physician to control postoperative pain.	Drug: Ibuprofen; Other Names: Caldolor
Placebo Comparator: Intravenous (IV) normal saline; 800mg normal saline before incision, followed by four total scheduled doses of IV ibuprofen every six hours for 24 hours, in addition to whatever narcotic or other pain control regimens prescribed by the treating physician to control postoperative pain.	Other: normal saline; Other Names: NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	pre-operative, 1-3 weeks post-operative, 6 months post-operative
Fusion rates	Assessed by plain x-rays or CT scans.	6 month post-operative

Collaborators and Investigators

• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Investigators: Principal Investigator: Nicholas Theodore, MD, St. Joseph Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 17, 2017

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimated): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Narcotic-Related Disorders; Pain, Postoperative; Opioid-Related Disorders; Spondylosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 13BN033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study was closed due to low enrollment. There was no data analysis done so there will be no information to share.