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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth

Tracking Information
First Submitted Date  ICMJE April 6, 2010
First Posted Date  ICMJE April 7, 2010
Last Update Posted Date April 7, 2010
Study Start Date  ICMJE April 2010
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2010)
VAS pain scales [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy
Official Title  ICMJE Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy: A Randomized Double-blind Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hemorrhoids
Intervention  ICMJE
  • 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.
  • Device: continuous infusion pump of bupivacaine
    bupivacaine 0.25% at 4ml/hr for 3 to 4 days
Study Arms  ICMJE
  • Placebo Comparator: Pump device
    One arm will have continuous subcutaneous infusion of normal saline.
    Intervention: Device: placement of a continuous infusion pump
  • Active Comparator: Bupivacaine
    will receive continuous infusion of bupivacaine
    Intervention: Device: continuous infusion pump of bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 6, 2010)
42
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01099605
Other Study ID Numbers  ICMJE CIP# 10.0042
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LT Ellie K Mentler, MC USN, NavalMCPortsmouth
Study Sponsor  ICMJE United States Naval Medical Center, Portsmouth
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account United States Naval Medical Center, Portsmouth
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP