CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
On-Q Pain Pumpdrug
Likely dose
Not stated in 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/NCT00533845
NCT00533845Phase 4Completed

Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery

Maimonides Medical Center·interventional·Posted Sep 24, 2007·Updated Apr 16, 2019

In Brief

A Phase 4 clinical trial evaluating On-Q Pain Pump for Postoperative Pain. Completed, enrolled 30 participants across 1 site.

Detailed Summary

After Laparoscopic surgery most patients experience some form of mild to moderate pain. The current standard of care is to treat this pain with local anesthetics (numbing medication, that deadens the nerve endings) to the small surgical incisions (cuts) and narcotic systemic analgesics (medication injected into your vein to control pain such as morphine). Although this treatment improves pain symptoms it is not perfect. Firstly, complete pain control is rarely achieved and secondly, narcotics (such as morphine) often have many side effects including nausea, vomiting, sedation (sleepiness), constipation and abdominal upset. All of these issues make recovery less comfortable and delays return to full function (work, school and other activities of daily life). A new FDA approved device is now available that offers the benefits of long term anesthesia without the side effects of narcotics. It consists of a pump that continuously infuses local anesthesia into and around the surgical site. This pump is placed during your operation. You then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing medicine around your wounds for 2 days continuously. The purpose of this study is to see if this pump improves postoperative pain, decreases the need for narcotic pain medicine and allows people to return to their activities earlier.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2007
Enrollment StartSep 1, 2007
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.8 years ago

Interventions

On-Q Pain Pumpdrug

Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally