Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01099605

Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy

Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy: A Randomized Double-blind Controlled Trial

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
United States Naval Medical Center, Portsmouth · Federal
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Accepted

Summary

Over the past decade, continuous wound infiltration systems have been introduced to treat a variety of post-surgical pain. These systems, commonly referred to pain pumps by patients, possess a catheter(s) attached to a reservoir of local anesthetic that directly infuses into the surgical site to provide local pain control thus avoiding the common and less desirable systemic effects of oral narcotic pain medication. Due to its portability, another benefit associated with these wound infiltration systems is its use as an outpatient pain control modality. Despite the apparent benefits, the verdict on the system's effectiveness in treating pain - throughout a variety of surgical fields - varies between very effective in reducing post-operative pain and reducing overall narcotic consumption for several days to completely ineffective with no reported changes in perceived pain or overall narcotic use. Through a randomized trial comparing plain saline to a common local anesthetic, The investigators hope to evaluate the effectiveness of these pain pumps as an outpatient modality for pain management following hemorrhoidectomy patients. The investigators hypothesize that there will be a significant benefit in pain relief with the use of these pumps.

Conditions

Interventions

TypeNameDescription
DEVICEplacement of a continuous infusion pumpEach infusion pump is placed below the mucosa of the rectum. Infusion of either the drug or saline will continue for approximately 3-4 days.
DEVICEcontinuous infusion pump of bupivacainebupivacaine 0.25% at 4ml/hr for 3 to 4 days

Timeline

Start date
2010-03-10
Primary completion
2013-09-09
Completion
2013-09-09
First posted
2010-04-07
Last updated
2025-07-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01099605. Inclusion in this directory is not an endorsement.