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

NCT ID: NCT02276911

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2017-07-17

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.

Conditions

Cervical Spondylosis; Lumbar Spondylosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: OTHER

Interventions

Ibuprofen

Intervention Type: DRUG

normal saline

Intervention Type: OTHER

Other Intervention Names

Caldolor; NS

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role: lead

Responsible Party

Lori Wood

Clinical Research Operations Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Theodore, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph Hospital and Medical Center

Locations

SJHMC/Barrow Neurosurgical Associates

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

13BN033

Identifier Type: -

Identifier Source: org_study_id