Cervical SpondylosisPhase 2NCT02276911
Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
A Phase 2 study testing Ibuprofen and normal saline in people with Cervical Spondylosis and Lumbar Spondylosis, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial summary
A prospective, randomized, placebo controlled, double-blinded study at a single institution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spondylosis, Lumbar Spondylosis
- What is being tested?
- Ibuprofen and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2015to 17 Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SJHMC/Barrow Neurosurgical Associates
Phoenix, Arizona, 85013
About this study
A prospective, randomized, placebo controlled, double-blinded study at a single institution.
Read the 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.
- Conditions
- Cervical Spondylosis, Lumbar Spondylosis
- Being tested
- Ibuprofen, normal saline
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Caldolor
normal salineOther
Also called NS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: pre-operative, 1-3 weeks post-operative, 6 months post-operative
Fusion rates
Assessed by plain x-rays or CT scans.
Measured: 6 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study start1 Mar 2015
- Primary completion1 Jun 2017
- Study completion17 Jul 2017
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Wood, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Nicholas Theodore, MD, Principal investigator, St. Joseph Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276911
- Sponsor's protocol ID
- 13BN033
- Status last verified
- Apr 2024
- First submitted
- 22 Oct 2014
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The study was closed due to low enrollment. There was no data analysis done so there will be no information to share.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02276911
- Acronym / sponsor ID
- 13BN033
- Conditions
- Cervical Spondylosis, Lumbar Spondylosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous (IV) ibuprofen | Active comparator | Drug: Ibuprofen800mg 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. |
| Intravenous (IV) normal saline | Placebo comparator | Other: normal saline800mg 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: Caldolor | Drug | Intravenous (IV) ibuprofen |
| normal salineAlso: NS | Other | Intravenous (IV) normal saline |
Primary outcome
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.
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.
Fusion rates
Time frame: 6 month post-operative
Assessed by plain x-rays or CT scans.
Results and safety
The study was stopped early (reason given: No enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No. The study was closed due to low enrollment. There was no data analysis done so there will be no information to share.
Related trials for Cervical Spondylosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
Recruiting
Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
Cervical Spondylosis
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Theodore, MD principal investigator
St. Joseph Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibuprofen and normal saline in people with Cervical Spondylosis and Lumbar Spondylosis, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain level (time frame: pre-operative, 1-3 weeks post-operative, 6 months post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.