Hemorrhoids
Conditions
Keywords
hemorrhoidectomy, pain management
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.
Interventions
DEVICEplacement 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.
DEVICEcontinuous infusion pump of bupivacaine
bupivacaine 0.25% at 4ml/hr for 3 to 4 days
Sponsors
United States Naval Medical Center, Portsmouth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Bupivacaine vs pump
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS pain scales | 1 week |
Countries
United States
Outcome results
None listed