Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Completed · Phase 3

Conditions studied: Hemorrhoids

In brief

Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Key facts

Study ID

NCT00744848

Run by

Pacira Pharmaceuticals, Inc

People needed

204

Starts

2008-08-01

Expected to finish

2009-02-01

Last updated by the study team

2013-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female equal or greater than 18 years of age at Screening
• 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.

You may not qualify if…

• Pregnant, nursing or planning to become pregnant during the study period
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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