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

St. Joseph's Hospital and Medical Center, Phoenix

Status and phase: Terminated; Phase 2

Conditions: Lumbar Spondylosis; Cervical Spondylosis

Treatments: Other: normal saline; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02276911

13BN033

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6 participants in 2 patient groups, including a placebo group

Intravenous (IV) ibuprofen

Active Comparator group

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.

Treatment:

Drug: Ibuprofen

Intravenous (IV) normal saline

Placebo Comparator group

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.

Treatment:

Other: normal saline