Status:
COMPLETED
Study of Pain Control in Hemorrhoidectomy
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Hemorrhoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.
Eligibility Criteria
Inclusion
- Age \> 18 years of age at the Screening visit
- American Society of Anesthesiologists (ASA) class 1-3
- Scheduled to have a two or three column excisional hemorrhoidectomy under general anesthesia using the Milligan-Morgan technique
- For female subjects, surgically sterile or at least two years menopausal, or using an acceptable method of birth control; must have a documented negative blood or urine pregnancy test within 24 hours before surgery
- Clinical lab values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator.
- Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
- Able to speak, read, and understand the language of all subject-facing documents, including the ICF and study questionnaires
- Able and willing to comply with all study visits and procedures
Exclusion
- Single-column hemorrhoidectomy or hemorrhoidectomy without an internal component
- Body weight less than 50 kilograms (110 pounds)
- History of hypersensitivity or idiosyncratic reactions or amide-type local anesthetics, opioids, or propofol
- Current painful physical condition or concurrent surgery other than hemorrhoids that may require analgesic treatment (such as non-steroidal anti-inflammatory drug \[NSAID\], opioid, selective serotonin reuptake inhibitor \[SSRI\], tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the hemorrhoidectomy procedure and may confound the postoperative assessments
- Concurrent fissurectomy
- Use of any NSAID including selective COX-2 inhibitor, opioid, SSRI, tricyclic antidepressant, gabapentin, or pregabalin within three days of surgery
- Use of acetaminophen within 24 hours of surgery
- Chronic users of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week
- History of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years
- Current use of glucocorticosteroids or use of glucocorticoids within one month of enrollment into this study
- HIV infection or hepatitis
- Currently pregnant, nursing, or planning to become pregnant during the course of the study or within one month of study drug administration
- Any psychiatric, psychological, medical, or laboratory condition that the investigator feels makes the subject an inappropriate candidate for this clinical trial
- Subjects who have received another investigational drug within the longer of the last 30 days or 10 elimination half-lives
- Previous participation in a SKY0402 study
- Failure to pass drug and alcohol screen
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00890721
Start Date
May 1 2009
End Date
November 1 2009
Last Update
August 6 2013
Active Locations (1)
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1
Prof. Zbigniew Śledziński
Gdansk, Poland