Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
Primary Purpose
Cervical Spondylosis, Lumbar Spondylosis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spondylosis
Eligibility 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
Sites / Locations
- SJHMC/Barrow Neurosurgical Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intravenous (IV) ibuprofen
Intravenous (IV) normal saline
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Change in overall health/function
SF-36 scores, total length of hospital stay, time to ambulation, and time to return to work.
Fusion rates
Assessed by plain x-rays or CT scans.
Secondary Outcome Measures
Full Information
NCT ID
NCT02276911
First Posted
October 22, 2014
Last Updated
September 20, 2021
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
1. Study Identification
Unique Protocol Identification Number
NCT02276911
Brief Title
Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
No enrollment
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
July 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, randomized, placebo controlled, double-blinded study at a single institution.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis, Lumbar Spondylosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous (IV) ibuprofen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intravenous (IV) normal saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Caldolor
Intervention Type
Other
Intervention Name(s)
normal saline
Other Intervention Name(s)
NS
Primary Outcome Measure Information:
Title
Change in pain level
Description
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
Title
Change in overall health/function
Description
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
Title
Fusion rates
Description
Assessed by plain x-rays or CT scans.
Time Frame
6 month post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Theodore, MD
Organizational Affiliation
St. Joseph Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SJHMC/Barrow Neurosurgical Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
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