|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01099605 |
|
Date of registration:
|
06/04/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy
|
|
Scientific title:
|
Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy: A Randomized Double-blind Controlled Trial |
|
Date of first enrolment:
|
April 2010 |
|
Target sample size:
|
42 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01099605 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Ellie Mentler, MD |
|
Address:
|
|
|
Telephone:
|
757-314-0134 |
|
Email:
|
ellie.mentler@med.navy.mil |
|
Affiliation:
|
|
|
|
Name:
|
Ellie Mentler, MD |
|
Address:
|
|
|
Telephone:
|
757-953-2454 |
|
Email:
|
ellie.mentler@med.navy.mil |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hemorrhoids
|
|
Intervention(s)
|
|
Device: continuous infusion pump of bupivacaine
|
|
Device: placement of a continuous infusion pump
|
|
Primary Outcome(s)
|
|
VAS pain scales
[Time Frame: 1 week]
|
|
Secondary ID(s)
|
|
CIP# 10.0042
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|