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Pain Pump for Hemorrhoids

Phase 4
Waitlist Available
Research Sponsored by United States Naval Medical Center, Portsmouth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled for hemorrhoidectomies at NMCP
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights

Study Summary

This trial is comparing the use of a pain pump (a machine that gives pain medicine directly to the surgical site) to no pain pump, to see if the pump is effective in reducing post-operative pain for people who have had surgery to remove hemorrhoids.

Who is the study for?
This trial is for patients scheduled for hemorrhoidectomies who are not pregnant, have no active infections at the site, haven't had previous surgeries for hemorrhoids (except simple incision), aren't allergic to local anesthetics or oral pain meds, don't suffer from chronic pain, and have no adverse reactions to NSAIDs.Check my eligibility
What is being tested?
The study tests a continuous infusion pump delivering bupivacaine directly into the surgical site against plain saline. The goal is to see if this method reduces post-operative pain and narcotic use after outpatient hemorrhoidectomy procedures.See study design
What are the potential side effects?
Potential side effects may include localized reactions at the infusion site such as irritation or infection, possible numbness around the area due to the anesthetic effect of bupivacaine, and rare allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a hemorrhoid surgery at NMCP.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
VAS pain scales

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BupivacaineActive Control1 Intervention
will receive continuous infusion of bupivacaine
Group II: Pump devicePlacebo Group1 Intervention
One arm will have continuous subcutaneous infusion of normal saline.

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, PortsmouthLead Sponsor
31 Previous Clinical Trials
4,290 Total Patients Enrolled

Media Library

Bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT01099605 — Phase 4
Hemorrhoids Research Study Groups: Bupivacaine, Pump device
Hemorrhoids Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT01099605 — Phase 4
Bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT01099605 — Phase 4
Hemorrhoids Patient Testimony for trial: Trial Name: NCT01099605 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the United States Food and Drug Administration accepted Bupivacaine for use?

"Due to the status of Bupivacaine as a Phase 4 treatment, meaning it has already been approved for use, our team at Power gave it a safety rating of 3 out of 3."

Answered by AI

Is the team behind this research actively seeking participants?

"According to clinicaltrials.gov, the recruitment process for this particular trial has since been concluded; starting on April 1st 2010 and ceasing by the 6th of that same month. However, at present there exist 500 different studies currently recruiting participants."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
What site did they apply to?
Naval Medical Center Portsmouth
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Is it a pump that is IV picked?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I said it in my initial application. Let me know if you have questions.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy
2010. "Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01099605.
All > Exparel
~3 spots leftby Apr 2025
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