Clinical trial NCT01650519: A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery
Official title: A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroscopic Knee Surgery
Keywords: knee surgery, arthroscopy; orthopaedic, orthopedic surgery
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-07-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.

Detailed description: Non-steroidal anti-inflammatory drugs(NSAIDs) are an effective adjunct to opioid analgesia for moderate-severe pain, with improvement in the quality of pain relief and consistent evidence of opioid dose sparing. NSAIDs alone could provide effective analgesia post-surgery when mild-moderate pain is expected. There is also evidence that the use of NSAIDs, by avoiding or decreasing the need for opioids, can lead to a reduction in the incidence of adverse events which are commonly attributed to, or exacerbated by, opioids.

The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for knee arthroscopy

Exclusion Criteria:

* Inadequate intravenous (IV) access.
* History of allergy or hypersensitivity to any component of ibuprofen or other NSAIDs, aspirin (or aspirin related products), opioids or cyclooxygenase-2(COX-2) inhibitors.
* Less than 18 years of age.
* Use of analgesics less than 8 hours prior to surgery.
* Patients with active, clinically significant anemia.
* History or evidence of asthma or heart failure.
* Pregnant.
* Recent history of chronic non-steroidal anti-inflammatory drug (NSAID) or opioid use.
* Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions and to return for the required assessments.
* Refusal to provide written authorization for use and disclosure of protected health information.

Primary outcomes:
measure: Efficacy of IV Ibuprofen for Post-op Pain.
timeFrame: first possible assessment following surgery
Secondary outcomes:
measure: Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge
timeFrame: 24 hours
measure: Time to Discharge.
timeFrame: 24 hours
measure: Patient Satisfaction.
timeFrame: 24 hours
measure: Incidence of Serious Adverse Events (SAEs).
timeFrame: 24 hours
measure: Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours
timeFrame: 24 Hours
measure: Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge
timeFrame: 24 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University, Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Fernando L Arbona, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uribe AA, Arbona FL, Flanigan DC, Kaeding CC, Palettas M, Bergese SD. Comparing the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain Following Arthroscopic Knee Surgery. A Randomized Double-Blind Active Comparator Pilot Study. Front Surg. 2018 Oct 3;5:59. doi: 10.3389/fsurg.2018.00059. eCollection 2018.