A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery

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.

Study Overview

• Status: Completed
• Conditions: Arthroscopic Knee Surgery
• Intervention / Treatment: Drug: IV ibuprofen; Drug: IV ketorolac

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University, Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: IV ibuprofen; Intravenous ibuprofen (800 mg) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 (Ibuprofen arm) and a corresponding volume of normal saline (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure	Drug: IV ibuprofen; 800 mg intravenous ibuprofen administered intravenously over 10 minutes.; Other Names: Caldolor
ACTIVE_COMPARATOR: IV ketorolac; A corresponding volume of normal saline (Ibuprofen arm) administered intravenously over 10 minutes at study hour 0 and again at study hour 4 and 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) (ketorolac arm) will be administered intravenously over no less than 15 seconds at the end of the arthroscopic procedure	Drug: IV ketorolac; 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds; Other Names: Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of IV Ibuprofen for Post-op Pain.	Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100.	first possible assessment following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measurement of the amount of rescue medication in the postoperative period.	24 hours
Time to Discharge.	Measurement of the time to discharge in the postoperative period.	24 hours
Patient Satisfaction.	Measurement of patient satisfaction post-procedure. During the post-treatment period, subjects were asked to complete a satisfaction questionnaire (Quality of Recovery - 40 or QoR-40) defining their quality of recovery at 24 hours following surgery. The QoR - 40 is a 40-item questionnaire that provides a global score and subscores across five dimensions of quality of recovery: emotions (minimum score = 6, maximum score = 30), physical comfort (minimum score = 8, maximum score = 40), patient support (minimum score = 7, maximum score = 35), physical independence (minimum score = 5, maximum score = 25), and pain (minimum score = 7, maximum score = 35). Higher subscores represent a better outcome. Subscores are added to create a Global QoR-40 score. Global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).	24 hours
Incidence of Serious Adverse Events (SAEs).	Measurement of the incidence of serious adverse events.	24 hours
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	Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) in the post-surgical period through 24 hours post-procedure. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. Subject's were contacted at 24 hour post-discharge during a follow-up phone contact and asked to completed the VAS at Rest and VAS with Movement and return both completed VAS assessments via the envelope provided. The analysis was performed on the VAS assessments returned to the study site.	24 Hours
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	Measurement of the amount of time to rescue medication in the postoperative period.	24 hours

Collaborators and Investigators

• Sponsor: Cumberland Pharmaceuticals
• Investigators: Principal Investigator: Fernando L Arbona, MD, The Ohio State University Wexner Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (ESTIMATE): July 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 23, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: knee surgery, arthroscopy; orthopaedic, orthopedic surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ibuprofen
• Other Study ID Numbers: CPI-CL-017