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| Name | Class |
|---|---|
| I-Flow | INDUSTRY |
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After surgery it is normal to experience some pain at the site of operation. In order to reduce the pain, medication such as Morphine is injected into a vein using a Patient Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient when needed. However, Morphine is an opioid drug, which can cause side effects such as sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects of morphine. Recently a portable device called ON-Q pump has been developed to continuously infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses the drug through the catheters by elastic force. This pump is very safe and is attached to a bedside pole or the patient's hospital gown. This pump has already been approved by the FDA for clinical use, and has been reported to provide effective pain management after some surgical procedures.
The primary aim of the present study is to evaluate the relative efficacy of the drugs Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used for post operative pain relief. Our hypothesis is that these two drugs in combination will provide better analgesia than Ketorolac alone.
This study would include a total of 60 patients randomized into 2 equal groups. Patients will be interviewed in the holding area and informed signed consent will be obtained. Patients will be induced with general anesthesia in keeping with standard practice. At the end of surgical procedure, before the patient is extubated, the Surgeon will secure the 2 catheters of the ON-Q pump at two levels of the fascia near the incision site. First the surgeon will instill at the wound site a bolus dose of 30 ml of 0.9% saline with 10 mg Ketorolac in Group I, or 30 ml of saline with 0.5% Ropivacaine and 10 mg Ketorolac in Group II patients. Then the continuous infusion with the ON-Q pump will be started at 4 ml/hr, and Group I patients will receive saline with Ketorolac at 5 mg/hr not to exceed 120 mg per day, and Group II will receive saline with 0.5% Ropivacaine plus Ketorolac at 5 mg/hr. Patients will be extubated, as per standard anesthetic practice. All patients will receive anti ulcer medication. On arrival at the Post Anesthesia Care Unit (PACU), the patient will receive an i.v. PCA pump, which will administer Morphine Sulfate 2 mg in incremental doses on demand by the patient.
A blinded investigator will collect the study data from each patient at 6, 12, 24, and 48 hrs postoperative periods. The data collected would include 1) Visual Analog Scale (VAS) scores for pain at rest, on coughing and on moving, 2) PCA demands by the patient and actual deliveries of morphine, 3) "rescue" analgesic requirements (for pain score of 4 or greater). 4) VAS scores for Nausea, drowsiness, and satisfaction, and 5) number of vomiting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Active Comparator | Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day |
|
| Ketorolac with Ropivacaine | Experimental | Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores at Rest | Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | 1 hour after the surgery |
| Pain Score at Rest | Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | At the end of 6 hours after surgery |
| Pain Scores at Rest | Pain scores at rest were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | 48 hours after surgery |
| Pain Score on Coughing | Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | 1 hour after the surgery |
| Pain Scores on Coughing | Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 6 hours after surgery. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | 6 hours after surgery |
| Pain Scores on Coughing | Pain scores on coughing were measured using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalents Utilization | Utilization of morphine and morpine equivalents for rescue analgesia was reviewed and calculated in milligrams. | 1 hour after surgery |
| Morphine Equivalents | Utilization of morphine and morphine equivalents for rescue analgesia was reviewed and calculated in milligrams. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kalpana Tyagaraj, M.D. | Maimonides Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac | Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day |
| FG001 | Ketorolac With Rpopivacaine | Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% via an infusion catheter at the incision siteKetorolac and Ropivacaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group.
Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study.
Reason for omission- Physician decision.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac | Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day |
| BG001 | Ketorolac With Ropivacaine | Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group. Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study. Reason for omission- Physician decision. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Scores at Rest | Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | Posted | Mean | Standard Deviation | units on a scale | 1 hour after the surgery |
|
one year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketorolac | Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kalpana Tyagaraj, M.D. | Maimonides Medical Center | 718-283-9162 | Kalpana_tyagaraj@msn.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ketorolac and Ropivacaine | Drug | Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine |
|
|
| 48 hours after surgery |
| Pain on Movement | Pain scores on movement was assessed using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | 1 hour after surgery |
| Pain Scores on Movement | Pain scores on movement were assessed using the Visual Analog Scale (VAS) at the end of 6 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | 6 hours after surgery |
| Pain on Movement | Pain scores on movement were measured 48 hours after surgery using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | 48 hours afetr surgery |
| 12 hours after surgery |
| Morphine Equivalents | Utilization of morphine and morphine equivalents for rescue analgesia, was reviewed and calculated in milligrams. | 48 hours afetr surgery |
| DROWSINESS | The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally drowsy and "10" meaning maximally drowsy. | 1 hour after surgery |
| DROWSINESS | The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally drowsy and "10" meaning maximally drowsy. | 48 hours |
| NAUSEA | The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally nauseous and "10" meaning maximally nauseous. | 1 hour after surgery |
| NAUSEA | The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally nauseous and "10" meaning maximally nauseous. | 48 hours |
| VOMITING | Data on number of episodes of vomiting was obtained, 6 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting. | 6 hours after surgery |
| VOMITING | Data on number of episodes of vomiting was obtained, 12 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting. | 12 hours |
| PATIENT SATISFACTION | Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, "1" indicating least satisfied and "10" indication very well satisfied. | 1 hour after surgery |
| PATIENT SATISFACTION | Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, "1" indicating least satisfied and "10" indication very well satisfied. | 48 hours afetr surgery |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group. Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study. Reason for omission- Physician decision. | Count of Participants | Participants |
|
| Region of Enrollment | Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group. Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study. Reason for omission- Physician decision. | Count of Participants | Participants |
|
| Pain score | Patients report pain scores using Visual Analog Scale (VAS) . This scale measures the severity of pain and ranges from from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group. Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study. Reason for omission- Physician decision. | Mean | Standard Deviation | units on a scale |
|
| Rescue analgesia utilization | Data is obtained regarding use of additional pain medications for breakthrough pain like morphine and acetaminophen with codeine. Rescue analgesics are converted to morphine equivalents and reported in milligrams. | Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group. Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study. Reason for omission- Physician decision. | Mean | Standard Deviation | milligrams |
|
| Age | Age of the participating patients, reported in years. | Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group. Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study. Reason for omission- Physician decision. | Median | Full Range | years |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Pain Score at Rest | Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | Posted | Mean | Standard Deviation | units on a scale | At the end of 6 hours after surgery |
|
|
|
| Primary | Pain Scores at Rest | Pain scores at rest were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | Posted | Mean | Standard Deviation | units on a scale | 48 hours after surgery |
|
|
|
| Primary | Pain Score on Coughing | Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | Posted | Mean | Standard Deviation | units on a scale | 1 hour after the surgery |
|
|
|
| Primary | Pain Scores on Coughing | Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 6 hours after surgery. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | Posted | Mean | Standard Deviation | units on a scale | 6 hours after surgery |
|
|
|
| Primary | Pain Scores on Coughing | Pain scores on coughing were measured using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | Posted | Mean | Standard Deviation | units on a scale | 48 hours after surgery |
|
|
|
| Primary | Pain on Movement | Pain scores on movement was assessed using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | Posted | Mean | Standard Deviation | units on a scale | 1 hour after surgery |
|
|
|
| Primary | Pain Scores on Movement | Pain scores on movement were assessed using the Visual Analog Scale (VAS) at the end of 6 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | Posted | Mean | Standard Deviation | units on a scale | 6 hours after surgery |
|
|
|
| Primary | Pain on Movement | Pain scores on movement were measured 48 hours after surgery using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity. | Posted | Mean | Standard Deviation | units on a scale | 48 hours afetr surgery |
|
|
|
| Secondary | Morphine Equivalents Utilization | Utilization of morphine and morpine equivalents for rescue analgesia was reviewed and calculated in milligrams. | Posted | Mean | Standard Deviation | miliigrams | 1 hour after surgery |
|
|
|
| Secondary | Morphine Equivalents | Utilization of morphine and morphine equivalents for rescue analgesia was reviewed and calculated in milligrams. | Posted | Mean | Standard Deviation | milligrams | 12 hours after surgery |
|
|
|
| Secondary | Morphine Equivalents | Utilization of morphine and morphine equivalents for rescue analgesia, was reviewed and calculated in milligrams. | Posted | Mean | Standard Deviation | milligrams | 48 hours afetr surgery |
|
|
|
| Secondary | DROWSINESS | The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally drowsy and "10" meaning maximally drowsy. | Posted | Mean | Standard Deviation | units on a scale | 1 hour after surgery |
|
|
|
| Secondary | DROWSINESS | The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally drowsy and "10" meaning maximally drowsy. | Posted | Mean | Standard Deviation | units on a scale | 48 hours |
|
|
|
| Secondary | NAUSEA | The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally nauseous and "10" meaning maximally nauseous. | Posted | Mean | Standard Deviation | units on a scale | 1 hour after surgery |
|
|
|
| Secondary | NAUSEA | The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally nauseous and "10" meaning maximally nauseous. | Posted | Mean | Standard Deviation | units on a scale | 48 hours |
|
|
|
| Secondary | VOMITING | Data on number of episodes of vomiting was obtained, 6 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting. | Posted | Mean | Standard Deviation | EPISODES | 6 hours after surgery |
|
|
|
| Secondary | VOMITING | Data on number of episodes of vomiting was obtained, 12 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting. | Posted | Mean | Standard Deviation | EPISODES | 12 hours |
|
|
|
| Secondary | PATIENT SATISFACTION | Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, "1" indicating least satisfied and "10" indication very well satisfied. | Posted | Mean | Standard Deviation | units on a scale | 1 hour after surgery |
|
|
|
| Secondary | PATIENT SATISFACTION | Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, "1" indicating least satisfied and "10" indication very well satisfied. | Posted | Mean | Standard Deviation | units on a scale | 48 hours afetr surgery |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Ketorolac and Ropivacainr | Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |