Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276911
Recruitment Status : Terminated (No enrollment)
First Posted : October 28, 2014
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix

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

Condition or disease Intervention/treatment Phase
Cervical Spondylosis Lumbar Spondylosis Drug: Ibuprofen Other: normal saline Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : July 17, 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: NS




Primary Outcome Measures :
  1. Change in pain level [ Time Frame: pre-operative, 1-3 weeks post-operative, 6 months post-operative ]
    Visual Analog Scale (VAS) scores at rest and with movement, Macqill Pain Questionnaire scores, and total morphine and morphine equivalents used during hospital admission.

  2. Change in overall health/function [ Time Frame: pre-operative, 1-3 weeks post-operative, 6 months post-operative ]
    SF-36 scores, total length of hospital stay, time to ambulation, and time to return to work.

  3. Fusion rates [ Time Frame: 6 month post-operative ]
    Assessed by plain x-rays or CT scans.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276911


Locations
Layout table for location information
United States, Arizona
SJHMC/Barrow Neurosurgical Associates
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
Layout table for investigator information
Principal Investigator: Nicholas Theodore, MD St. Joseph Hospital and Medical Center
Layout table for additonal information
Responsible Party: Pam Dewey, Clinical Research Operations Manager, St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT02276911    
Other Study ID Numbers: 13BN033
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylosis
Pain, Postoperative
Opioid-Related Disorders
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action