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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT01099605
First received: April 6, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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 Intervention Phase
Hemorrhoids
Device: placement of a continuous infusion pump
Device: continuous infusion pump of bupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, Portsmouth:

Primary Outcome Measures:
  • VAS pain scales [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: April 2010
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099605

Contacts
Contact: Ellie Mentler, MD 757-953-2454 ellie.mentler@med.navy.mil

Locations
United States, Virginia
Naval Medical Center Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708
Contact: Ellie Mentler, MD    757-314-0134    ellie.mentler@med.navy.mil   
Principal Investigator: Ellie Mentler, MD         
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
  More Information

No publications provided

Responsible Party: LT Ellie K Mentler, MC USN, NavalMCPortsmouth
ClinicalTrials.gov Identifier: NCT01099605     History of Changes
Other Study ID Numbers: CIP# 10.0042
Study First Received: April 6, 2010
Last Updated: April 6, 2010
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, Portsmouth:
hemorrhoidectomy
pain management

Additional relevant MeSH terms:
Hemorrhoids
Pain, Postoperative
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pain
Pathologic Processes
Postoperative Complications
Rectal Diseases
Signs and Symptoms
Vascular Diseases
Anesthetics
Anesthetics, Local
Bupivacaine
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014