CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 67 enrolled
Drug / intervention
Ketorolac +1 moredrug
Likely dose
Ketorolac 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00638508
NCT00638508Phase 4Completed

The Analgesic Efficacy of Continuous Infusion of Ketorolac and Ropivacaine at the Wound Site Using ON-Q Pump for Postoperative Pain Management

Maimonides Medical Center·interventional·Posted Mar 19, 2008·Updated Aug 7, 2018

In Brief

A Phase 4 clinical trial evaluating Ketorolac and Ketorolac and Ropivacaine for Postoperative Pain. Completed, enrolled 67 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsI-Flow

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 19, 2008
Enrollment StartJun 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.3 years ago

Interventions

Ketorolacdrug

Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day

Ketorolac and Ropivacainedrug

Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine