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

NCT ID: NCT01099605

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-10
• Study Completion Date: 2013-09-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pump device

One arm will have continuous subcutaneous infusion of normal saline.

Group Type: PLACEBO_COMPARATOR

placement of a continuous infusion pump

Intervention Type: 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.

Bupivacaine

will receive continuous infusion of bupivacaine

Group Type: ACTIVE_COMPARATOR

continuous infusion pump of bupivacaine

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

continuous infusion pump of bupivacaine

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for hemorrhoidectomies at NMCP

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Naval Medical Center, Portsmouth

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Countries

United States

Other Identifiers

CIP# 10.0042

Identifier Type: -

Identifier Source: org_study_id