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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01099605
Recruitment Status : Unknown
Verified April 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was:  Recruiting
First Posted : April 7, 2010
Last Update Posted : April 7, 2010
Information provided by:
United States Naval Medical Center, Portsmouth

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.

Condition or disease Intervention/treatment Phase
Hemorrhoids Device: placement of a continuous infusion pump Device: continuous infusion pump of bupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy: A Randomized Double-blind Controlled Trial
Study Start Date : April 2010
Estimated Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Pump device
One arm will have continuous subcutaneous infusion of normal saline.
Device: 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.

Active Comparator: Bupivacaine
will receive continuous infusion of bupivacaine
Device: continuous infusion pump of bupivacaine
bupivacaine 0.25% at 4ml/hr for 3 to 4 days

Primary Outcome Measures :
  1. VAS pain scales [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01099605

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Contact: Ellie Mentler, MD 757-953-2454

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United States, Virginia
Naval Medical Center Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708
Contact: Ellie Mentler, MD    757-314-0134   
Principal Investigator: Ellie Mentler, MD         
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
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Responsible Party: LT Ellie K Mentler, MC USN, NavalMCPortsmouth Identifier: NCT01099605    
Other Study ID Numbers: CIP# 10.0042
First Posted: April 7, 2010    Key Record Dates
Last Update Posted: April 7, 2010
Last Verified: April 2010
Keywords provided by United States Naval Medical Center, Portsmouth:
pain management
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents