HemorrhoidsNCT01099605
Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy
A study testing placement of a continuous infusion pump and continuous infusion pump of bupivacaine in people with Hemorrhoids, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- placement of a continuous infusion pump and continuous infusion pump of bupivacaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2010to 9 Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for hemorrhoidectomies at NMCP
Who cannot join
- Any patient with co-existing active purulent infection (i.e. abscess).
- Any patient who has had previous surgical intervention for his/her hemorrhoidal disease. Previous simple incision to treat a thrombosed hemorrhoid is not considered a surgical intervention for the purposes of this study. The minimal scar produced by a small incision would not alter post-operative pain following removal of a hemorrhoidal column.
- Any patient allergic to local anesthetics or oral pain medications
- Any patient with a history of chronic pain
- Any patient allergic to or has had an adverse reaction (i.e. history of gastrointestinal bleed) to a non-steroidal anti-inflammatory drugs (NSAIDs)
- Any patient pregnant patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
Official title: Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy: A Randomized Double-blind Controlled Trial
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
- Hemorrhoids
- Being tested
- placement of a continuous infusion pump, continuous infusion pump of bupivacaine
- Keywords
- hemorrhoidectomy, pain management
- Medical subject headings
- Hemorrhoids, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of a continuous infusion pumpDevice
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.
continuous infusion pump of bupivacaineDevice
bupivacaine 0.25% at 4ml/hr for 3 to 4 days
| Study group | Role | What they receive |
|---|---|---|
| Pump device | Placebo comparator | One arm will have continuous subcutaneous infusion of normal saline. Receives: Device: placement of a continuous infusion pump |
| Bupivacaine | Active comparator | will receive continuous infusion of bupivacaine Receives: Device: continuous infusion pump of bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain scales
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study start10 Mar 2010
- Primary completion9 Sep 2013
- Study completion9 Sep 2013
Why it stopped: No recruitment occurred and PI stopped the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Bupivacaine vs pump
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099605
- Sponsor's protocol ID
- CIP# 10.0042
- Status last verified
- Jul 2025
- First submitted
- 6 Apr 2010
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy: A Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01099605
- Acronym / sponsor ID
- CIP# 10.0042
- Conditions
- Hemorrhoids
- Keywords
- hemorrhoidectomy, pain management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment occurred and PI stopped the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- 10 Mar 2010 (actual)
- Primary completion
- 9 Sep 2013 (actual)
- Study completion
- 9 Sep 2013 (actual)
- First posted
- 7 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Bupivacaine vs pump
| Arm | Type | Receives |
|---|---|---|
| Pump device | Placebo comparator | Device: placement of a continuous infusion pumpOne arm will have continuous subcutaneous infusion of normal saline. |
| Bupivacaine | Active comparator | Device: continuous infusion pump of bupivacainewill receive continuous infusion of bupivacaine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for hemorrhoidectomies at NMCP
Key exclusion criteria (6 listed)
- Any patient with co-existing active purulent infection (i.e. abscess).
- Any patient who has had previous surgical intervention for his/her hemorrhoidal disease. Previous simple incision to treat a thrombosed hemorrhoid is not considered a surgical intervention for the purposes of this study. The minimal scar produced by a small incision would not alter post-operative pain following removal of a hemorrhoidal column.
- Any patient allergic to local anesthetics or oral pain medications
- Any patient with a history of chronic pain
- Any patient allergic to or has had an adverse reaction (i.e. history of gastrointestinal bleed) to a non-steroidal anti-inflammatory drugs (NSAIDs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placement 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. | Device | Pump device |
| continuous infusion pump of bupivacainebupivacaine 0.25% at 4ml/hr for 3 to 4 days | Device | Bupivacaine |
Primary outcome
VAS pain scales
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing placement of a continuous infusion pump and continuous infusion pump of bupivacaine in people with Hemorrhoids, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain scales (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.