Arthroscopic Knee SurgeryPhase 4NCT01650519
A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery
A Phase 4 study testing IV ibuprofen and IV ketorolac in people with Arthroscopic Knee Surgery, run by Cumberland Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopic Knee Surgery
- What is being tested?
- IV ibuprofen and IV ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for knee arthroscopy
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University, Wexner Medical Center
Columbus, Ohio, 43210
About this study
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.
Read the 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.
- Conditions
- Arthroscopic Knee Surgery
- Being tested
- IV ibuprofen, IV ketorolac
- Keywords
- knee surgery, arthroscopy; orthopaedic, orthopedic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ibuprofenDrug
Also called Caldolor
800 mg intravenous ibuprofen administered intravenously over 10 minutes.
IV ketorolacDrug
Also called Toradol
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
| Study group | Role | What they receive |
|---|---|---|
| IV ibuprofen | Active comparator | 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 Receives: Drug: IV ibuprofen |
| IV ketorolac | Active comparator | 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 Receives: Drug: IV ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: first possible assessment following surgery
Secondary outcomes (6)
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.
Measured: 24 hours
Time to Discharge.
Measurement of the time to discharge in the postoperative period.
Measured: 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).
Measured: 24 hours
Incidence of Serious Adverse Events (SAEs).
Measurement of the incidence of serious adverse events.
Measured: 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.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroscopic Knee SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando L Arbona, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650519
- Sponsor's protocol ID
- CPI-CL-017
- Status last verified
- May 2016
- First submitted
- 24 Jul 2012
- Last updated
- 23 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 30338261
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery
- ClinicalTrials.gov ID
- NCT01650519
- Acronym / sponsor ID
- CPI-CL-017
- Conditions
- Arthroscopic Knee Surgery
- Keywords
- knee surgery, arthroscopy; orthopaedic, orthopedic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Posted 10 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV ibuprofen | Active comparator | Drug: IV ibuprofenIntravenous 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 |
| IV ketorolac | Active comparator | Drug: IV ketorolacA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for knee arthroscopy
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV ibuprofenAlso: Caldolor800 mg intravenous ibuprofen administered intravenously over 10 minutes. | Drug | IV ibuprofen |
| IV ketorolacAlso: Toradol30 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 | Drug | IV ketorolac |
Primary outcome
Efficacy of IV Ibuprofen for Post-op Pain.
Time frame: first possible assessment following surgery
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.
6 secondary outcomes
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
Time frame: 24 hours
Time to Discharge.
Time frame: 24 hours
Patient Satisfaction.
Time frame: 24 hours
Incidence of Serious Adverse Events (SAEs).
Time frame: 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
Time frame: 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
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30338261Uribe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando L Arbona, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV ibuprofen and IV ketorolac in people with Arthroscopic Knee Surgery, run by Cumberland Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of IV Ibuprofen for Post-op Pain. (time frame: first possible assessment following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01650519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.