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

Cervical Spondylosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02276911
• Other study ID #: 13BN033
• Status: Terminated
• Phase: Phase 2
• Start date: March 1, 2015
• Est. completion date: July 17, 2017

Study information

• Verified date: April 2024
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 17, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spondylosis
• Lumbar Spondylosis
• Opioid-Related Disorders
• Pain, Postoperative
• Spondylosis

Intervention

Drug:
• Ibuprofen

Other:
• normal saline

Locations

Country	Name	City	State
United States	SJHMC/Barrow Neurosurgical Associates	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre-operative, 1-3 weeks post-operative, 6 months post-operative
Primary	Change in overall health/function	SF-36 scores, total length of hospital stay, time to ambulation, and time to return to work.	pre-operative, 1-3 weeks post-operative, 6 months post-operative
Primary	Fusion rates	Assessed by plain x-rays or CT scans.	6 month post-operative