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

United States Naval Medical Center, Portsmouth

Status: Withdrawn

Conditions: Hemorrhoids

Treatments: Device: placement of a continuous infusion pump; Device: continuous infusion pump of bupivacaine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01099605

CIP# 10.0042

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups, including a placebo group

Pump device

Placebo Comparator group

Description:

One arm will have continuous subcutaneous infusion of normal saline.

Treatment:

Device: placement of a continuous infusion pump

Bupivacaine

Active Comparator group

Description:

will receive continuous infusion of bupivacaine

Treatment:

Device: continuous infusion pump of bupivacaine