Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
NCT ID: NCT00744848
Last Updated: 2013-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
204 participants
INTERVENTIONAL
2008-08-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Bupivacaine HCl
100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration.
Bupivacaine HCl
100 mg Bupivacaine HCl
SKY0402
300 mg SKY0402 in a 40-mL injection volume.
A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration.
SKY0402
Single administration 300 mg SKY0402 in a 40-mL injection volume
Interventions
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Bupivacaine HCl
100 mg Bupivacaine HCl
SKY0402
Single administration 300 mg SKY0402 in a 40-mL injection volume
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy.
* Scheduled to undergo 2-or3-column excisional hemorrhoidectomy
* American Society of Anesthesiology (ASA) Physical Class 1-4
* Able and willing to complete with all study visits and procedures
* Able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments
* Willing and capable of provide written informed consent.
Exclusion Criteria
* Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery.
* Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments.
* Single-column hemorrhoidectomy
* Body weight less than 50 kg (110 pounds)
* History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in Marcaine with epinephrine)
* contraindication to epinephrine
* contraindication to any of the pain-control agents planned for postoperative use
* Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration
* History of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years.
* Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance.
* Significant medical conditions or laboratory results that indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial.
* Any clinically significant event or condition uncovered during surgery
* A cumulative incision length less than 3 cm
18 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Kay Warnott, RN, ACN-P
Role: STUDY_DIRECTOR
Pacira Pharmaceuticals, Inc
Locations
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West Alabama Research Inc.
Birmingham, Alabama, United States
Drug Research and Analysis Corporation
Montgomery, Alabama, United States
Lotus Clinical Research - Huntington Memorial Hospital
Pasadena, California, United States
Accurate Clinical Trials
San Clemente, California, United States
UCSD Medical Center
San Diego, California, United States
Colon and Rectal Disease Center
Orlando, Florida, United States
University of Illinois
Springfield, Illinois, United States
Indiana University - Wishard Memorial Hospital
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Mount Sinai Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
CTMG, Inc. - Pitt Medical Center
Greenville, North Carolina, United States
Univ. Hospitals of Cleveland, Case Medical Center
Cleveland, Ohio, United States
Holston Medical Group
Kingsport, Tennessee, United States
Research Concepts, Ltd
Bellaire, Texas, United States
Medical Center Ambulatory Surgery Center
Houston, Texas, United States
The Women's Hospital of Texas
Houston, Texas, United States
Roland Saenz
San Antonio, Texas, United States
Multicare Health System
Tacoma, Washington, United States
Countries
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References
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Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
Other Identifiers
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SIMPLE Hemorrhoidectomy 312
Identifier Type: -
Identifier Source: org_study_id