Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy
Primary Purpose
Hemorrhoids
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
placement of a continuous infusion pump
continuous infusion pump of bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids focused on measuring hemorrhoidectomy, pain management
Eligibility 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
Sites / Locations
- Naval Medical Center PortsmouthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Pump device
Bupivacaine
Arm Description
One arm will have continuous subcutaneous infusion of normal saline.
will receive continuous infusion of bupivacaine
Outcomes
Primary Outcome Measures
VAS pain scales
Secondary Outcome Measures
Full Information
NCT ID
NCT01099605
First Posted
April 6, 2010
Last Updated
April 6, 2010
Sponsor
United States Naval Medical Center, Portsmouth
1. Study Identification
Unique Protocol Identification Number
NCT01099605
Brief Title
Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy
Official Title
Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy: A Randomized Double-blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
United States Naval Medical Center, Portsmouth
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
hemorrhoidectomy, pain management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pump device
Arm Type
Placebo Comparator
Arm Description
One arm will have continuous subcutaneous infusion of normal saline.
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
will receive continuous infusion of bupivacaine
Intervention Type
Device
Intervention Name(s)
placement of a continuous infusion pump
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
continuous infusion pump of bupivacaine
Intervention Description
bupivacaine 0.25% at 4ml/hr for 3 to 4 days
Primary Outcome Measure Information:
Title
VAS pain scales
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellie Mentler, MD
Phone
757-953-2454
Email
ellie.mentler@med.navy.mil
Facility Information:
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellie Mentler, MD
Phone
757-314-0134
Email
ellie.mentler@med.navy.mil
First Name & Middle Initial & Last Name & Degree
Ellie Mentler, MD
12. IPD Sharing Statement
Learn more about this trial
Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy
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