ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management
Information source: Maimonides Medical Center
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Ketorolac (Drug); Ketorolac and Ropivacaine (Drug)
Sponsored by: Maimonides Medical Center
Official(s) and/or principal investigator(s):
Kalpana Tyagaraj, M.D., Principal Investigator, Affiliation: Maimonides Medical Center
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.
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain score
Secondary outcome: Morphine utilization, Nausea, Vomiting, drowsiness
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.
Minimum age: 20 Years.
Maximum age: 80 Years.
- Patients belonging to ASA class I to II classification who are undergoing abdominal
gynecologic surgery will be included in the study.
- Patients who are allergic to NSAIDs, Asthmatics, and those who have peptic ulcer,
sepsis, or coagulation problems will be excluded from the study.
Locations and Contacts
Maimonides Medical Center, Brooklyn, New York 11219, United States; Recruiting
Kalpana Tyagaraj, M.D., Phone: 718-283-7317, Email: Kalpana_tyagaraj@msn.com
Murali Pagala, Ph.D., Phone: 718-283-7193, Email: firstname.lastname@example.org
Murali Pagala, Ph.D., Sub-Investigator
Starting date: June 2007
Last updated: March 18, 2008