Arthroscopic Knee Surgery
Conditions
Keywords
knee surgery, arthroscopy; orthopaedic, orthopedic surgery
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.
Interventions
DRUGIV ibuprofen
800 mg intravenous ibuprofen administered intravenously over 10 minutes.
DRUGIV 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
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of IV Ibuprofen for Post-op Pain. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Discharge. | 24 hours | Measurement of the time to discharge in the postoperative period. |
| Patient Satisfaction. | 24 hours | 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). |
| 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 | 24 hours | Measurement of the amount of rescue medication in the postoperative period. |
| 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 | 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. |
| 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 | 24 hours | Measurement of the amount of time to rescue medication in the postoperative period. |
| Incidence of Serious Adverse Events (SAEs). | 24 hours | Measurement of the incidence of serious adverse events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Ibuprofen 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.
IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes. | 20 |
| IV Ketorolac Either 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 at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.
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 | 31 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | IV Ibuprofen | IV Ketorolac |
|---|---|---|---|
| Age, Customized Subject greater than or equal to 18 years of age | 44 years STANDARD_DEVIATION 12.8 | 43 years STANDARD_DEVIATION 12.6 | 45 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 20 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 46 Participants | 17 Participants | 29 Participants |
| Region of Enrollment United States | 51 participants | 20 participants | 31 participants |
| Sex: Female, Male Female | 16 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 35 Participants | 14 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 31 |
| serious Total, serious adverse events | 0 / 20 | 0 / 31 |
Outcome results
Primary
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.
Time frame: first possible assessment following surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Ibuprofen | Efficacy of IV Ibuprofen for Post-op Pain. | VAS with Movement (mm) | 19 units on a scale | Standard Deviation 17.4 |
| IV Ibuprofen | Efficacy of IV Ibuprofen for Post-op Pain. | VAS at Rest (mm) | 8 units on a scale | Standard Deviation 6.6 |
| IV Ketorolac | Efficacy of IV Ibuprofen for Post-op Pain. | VAS with Movement (mm) | 41 units on a scale | Standard Deviation 25.8 |
| IV Ketorolac | Efficacy of IV Ibuprofen for Post-op Pain. | VAS at Rest (mm) | 34 units on a scale | Standard Deviation 25 |
Secondary
Incidence of Serious Adverse Events (SAEs).
Measurement of the incidence of serious adverse events.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Ibuprofen | Incidence of Serious Adverse Events (SAEs). | 0 Number of Events |
| IV Ketorolac | Incidence of Serious Adverse Events (SAEs). | 0 Number of Events |
Secondary
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.
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Ibuprofen | 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 | Narcotic | 5.4 milligrams | Standard Deviation 6.02 |
| IV Ibuprofen | 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 | Acetaminophen | 162.5 milligrams | Standard Deviation 229.81 |
| IV Ketorolac | 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 | Narcotic | 20.4 milligrams | Standard Deviation 15.87 |
| IV Ketorolac | 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 | Acetaminophen | 325 milligrams | Standard Deviation 269.9 |
Secondary
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Ibuprofen | 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 | 1.7 Hours | Standard Deviation 0.19 |
| IV Ketorolac | 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 | 1 Hours | Standard Deviation 0.11 |
Secondary
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.
Time frame: 24 Hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Ibuprofen | 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 | VAS with Movement (mm) | 12 units on a scale | Standard Error 12.2 |
| IV Ibuprofen | 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 | VAS at Rest (mm) | 4 units on a scale | Standard Error 3.7 |
| IV Ketorolac | 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 | VAS with Movement (mm) | 23 units on a scale | Standard Error 16.5 |
| IV Ketorolac | 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 | VAS at Rest (mm) | 13 units on a scale | Standard Error 10.8 |
Secondary
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).
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Ibuprofen | Patient Satisfaction. | Patient Support | 30.5 units on a scale | Standard Deviation 1.2 |
| IV Ibuprofen | Patient Satisfaction. | Emotions | 20.2 units on a scale | Standard Deviation 2.35 |
| IV Ibuprofen | Patient Satisfaction. | Pain | 9.5 units on a scale | Standard Deviation 3.45 |
| IV Ibuprofen | Patient Satisfaction. | Physical Comfort | 28.3 units on a scale | Standard Deviation 4.39 |
| IV Ibuprofen | Patient Satisfaction. | Physical Independence | 22.2 units on a scale | Standard Deviation 2.55 |
| IV Ketorolac | Patient Satisfaction. | Physical Comfort | 26.9 units on a scale | Standard Deviation 2.98 |
| IV Ketorolac | Patient Satisfaction. | Patient Support | 29.0 units on a scale | Standard Deviation 3.93 |
| IV Ketorolac | Patient Satisfaction. | Emotions | 20.7 units on a scale | Standard Deviation 2.25 |
| IV Ketorolac | Patient Satisfaction. | Pain | 10.9 units on a scale | Standard Deviation 3.34 |
| IV Ketorolac | Patient Satisfaction. | Physical Independence | 21.3 units on a scale | Standard Deviation 3.32 |
Secondary
Time to Discharge.
Measurement of the time to discharge in the postoperative period.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Ibuprofen | Time to Discharge. | 1.8 Hours | Standard Deviation 0.12 |
| IV Ketorolac | Time to Discharge. | 1.8 Hours | Standard Deviation 0.08 |