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

NCT01099605 | Withdrawn DMC

• 1 other identifier: CIP# 10.0042
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Hemorrhoids

Keywords

hemorrhoidectomy; pain management

Outcome Measures

Primary Outcomes (1)

• VAS pain scales

  1 week

Study Arms (2)

Pump device

PLACEBO COMPARATOR

One arm will have continuous subcutaneous infusion of normal saline.

Device: placement of a continuous infusion pump

Bupivacaine

ACTIVE COMPARATOR

will receive continuous infusion of bupivacaine

Device: continuous infusion pump of bupivacaine

Interventions

placement of a continuous infusion pump DEVICE

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.

Pump device

continuous infusion pump of bupivacaine DEVICE

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

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for hemorrhoidectomies at NMCP

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Hemorrhoids; Agnosia

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Bupivacaine vs pump

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 7, 2010
• Study Start: March 10, 2010
• Primary Completion: September 9, 2013
• Study Completion: September 9, 2013
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (1)