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

NCT01099605 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-07-20

No results posted yet for this study

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

DEVICE

placement of a continuous infusion pump

Each infusion pump is placed below the mucosa of the rectum. Infusion of either the drug or saline will continue for approximately 3-4 days.

DEVICE

continuous infusion pump of bupivacaine

bupivacaine 0.25% at 4ml/hr for 3 to 4 days

Sponsors & Collaborators

  • United States Naval Medical Center, Portsmouth

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-10
Primary Completion
2013-09-09
Completion
2013-09-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01099605 on ClinicalTrials.gov