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

• ClinicalTrials.gov Identifier: NCT02276911
• Recruitment Status: Terminated
• First Posted: October 28, 2014
• Last Update Posted: August 23, 2018
• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Information provided by (Responsible Party): Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Arizona

SJHMC/Barrow Neurosurgical Associates

Phoenix, Arizona, United States, 85013

Sponsors and Collaborators

St. Joseph's Hospital and Medical Center, Phoenix

Investigators

• Principal Investigator: Nicholas Theodore, MD; St. Joseph Hospital and Medical Center

More 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
• Last Update Posted: August 23, 2018
• Last Verified: August 2018

Additional relevant 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