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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Maimonides Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
I-Flow
Information provided by:
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT00638508
First received: March 12, 2008
Last updated: March 18, 2008
Last verified: March 2008
  Purpose

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 Intervention
Postoperative Pain
Drug: Ketorolac
Drug: Ketorolac and Ropivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Pain score [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morphine utilization, Nausea, Vomiting, drowsiness [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: June 2007
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
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: Group 2 Drug: Ketorolac and Ropivacaine
Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine
Other Name: Toradol and Naropin

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638508

Locations
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Kalpana Tyagaraj, M.D.    718-283-7317    Kalpana_tyagaraj@msn.com   
Contact: Murali Pagala, Ph.D.    718-283-7193    mpagala@maimonidesmed.org   
Sub-Investigator: Murali Pagala, Ph.D.         
Sponsors and Collaborators
Maimonides Medical Center
I-Flow
Investigators
Principal Investigator: Kalpana Tyagaraj, M.D. Maimonides Medical Center
  More Information

No publications provided

Responsible Party: Kalpana Tyagaraj, M.D., Attending Anesthesiologist, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00638508     History of Changes
Other Study ID Numbers: 06/07/VA3
Study First Received: March 12, 2008
Last Updated: March 18, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014