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

NCT02276911 | Terminated Phase 2

• 1 other identifier: 13BN033
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Spondylosis; Lumbar Spondylosis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intravenous (IV) ibuprofen

ACTIVE COMPARATOR

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

Intravenous (IV) normal saline

PLACEBO COMPARATOR

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

Interventions

Ibuprofen DRUG

Also known as: Caldolor

Intravenous (IV) ibuprofen

normal saline OTHER

Also known as: NS

Intravenous (IV) normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

Study Sites (1)

SJHMC/Barrow Neurosurgical Associates

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Spondylosis

Interventions

Ibuprofen; Saline Solution

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nicholas Theodore, MD

  St. Joseph Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Operations Manager

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 28, 2014
• Study Start: March 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 17, 2017
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)