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ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management

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ClinicalTrials.gov Identifier: NCT00638508
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
I-Flow
Information provided by (Responsible Party):
kalpana tyagaraj, Maimonides Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ketorolac Drug: Ketorolac and Ropivacaine Phase 4

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Analgesic Efficacy of Continuous Infusion of Ketorolac and Ropivacaine at the Wound Site Using ON-Q Pump for Postoperative Pain Management
Study Start Date : June 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ketorolac
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Drug: Ketorolac
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Other Name: Toradol

Experimental: Ketorolac with Ropivacaine
Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site
Drug: Ketorolac and Ropivacaine
Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine
Other Name: Toradol and Naropin




Primary Outcome Measures :
  1. Pain Scores at Rest [ Time Frame: 1 hour after the surgery ]
    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.

  2. Pain Score at Rest [ Time Frame: At the end of 6 hours after surgery ]
    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.

  3. Pain Scores at Rest [ Time Frame: 48 hours after surgery ]
    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.

  4. Pain Score on Coughing [ Time Frame: 1 hour after the surgery ]
    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.

  5. Pain Scores on Coughing [ Time Frame: 6 hours after surgery ]
    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. Pain Scores on Coughing [ Time Frame: 48 hours after surgery ]
    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.

  7. Pain on Movement [ Time Frame: 1 hour after surgery ]
    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.

  8. Pain Scores on Movement [ Time Frame: 6 hours after surgery ]
    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.

  9. Pain on Movement [ Time Frame: 48 hours afetr surgery ]
    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.


Secondary Outcome Measures :
  1. Morphine Equivalents Utilization [ Time Frame: 1 hour after surgery ]
    Utilization of morphine and morpine equivalents for rescue analgesia was reviewed and calculated in milligrams.

  2. Morphine Equivalents [ Time Frame: 12 hours after surgery ]
    Utilization of morphine and morphine equivalents for rescue analgesia was reviewed and calculated in milligrams.

  3. Morphine Equivalents [ Time Frame: 48 hours afetr surgery ]
    Utilization of morphine and morphine equivalents for rescue analgesia, was reviewed and calculated in milligrams.

  4. DROWSINESS [ Time Frame: 1 hour after surgery ]
    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.

  5. DROWSINESS [ Time Frame: 48 hours ]
    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.

  6. NAUSEA [ Time Frame: 1 hour after surgery ]
    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.

  7. NAUSEA [ Time Frame: 48 hours ]
    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.

  8. VOMITING [ Time Frame: 6 hours after surgery ]
    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.

  9. VOMITING [ Time Frame: 12 hours ]
    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.

  10. PATIENT SATISFACTION [ Time Frame: 1 hour after surgery ]
    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.

  11. PATIENT SATISFACTION [ Time Frame: 48 hours afetr surgery ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients belonging to ASA class I to II classification who are undergoing abdominal gynecologic surgery will be included in the study.

Exclusion Criteria:

  • Patients who are allergic to NSAIDs, Asthmatics, and those who have peptic ulcer, sepsis, or coagulation problems will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638508


Locations
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
I-Flow
Investigators
Principal Investigator: Kalpana Tyagaraj, M.D. Maimonides Medical Center

Responsible Party: kalpana tyagaraj, Attending, Anesthesiology, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00638508     History of Changes
Other Study ID Numbers: 06/07/VA3
First Posted: March 19, 2008    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action