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

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix (Other)

Overall Status

Terminated

CT.gov ID

NCT02276911

Collaborator

(none)

Enrollment

Location

Arms

28.6

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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

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 :

Mar 1, 2015

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jul 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 Names: 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 Names: NS

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 Names:

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 Names:

Outcome Measures

Primary Outcome Measures

Change in pain level [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 [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 [6 month post-operative]
Assessed by plain x-rays or CT scans.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lisa Arnold, Clinical Research Operations Manager, St. Joseph's Hospital and Medical Center, Phoenix

ClinicalTrials.gov Identifier:

NCT02276911

Other Study ID Numbers:

13BN033

First Posted:

Oct 28, 2014

Last Update Posted:

Sep 21, 2021

Last Verified:

Sep 1, 2021

Additional relevant MeSH terms:

Spondylosis

Pain, Postoperative

Opioid-Related Disorders

Ibuprofen

Study Results

No Results Posted as of Sep 21, 2021