Study of Pain Control in Hemorrhoidectomy - Full Text View

Purpose

Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.

Condition	Intervention	Phase
Hemorrhoid	Drug: SKY0402 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids

U.S. FDA Resources

Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:

The area under the curve (AUC) of the numeric rating scale (NRS-R) pain intensity scores through 72 hours for subjects receiving SKY0402 vs. placebo. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Participants with Adverse Events through 72 hours or Serious Adverse Events through 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment:	189
Study Start Date:	May 2009
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SKY0402 During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.	Drug: SKY0402 During the operation, 30cc of SKY0402 are injected into the wound.
Placebo Comparator: Placebo During the hemorrhoidectomy, 30cc Placebo injected into the wound.	Drug: Placebo During the hemorrhoidectomy, 30cc Placebo injected into the wound.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years of age at the Screening visit
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 Criteria:

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 NSAID, opioid, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890721

Locations

Poland
Prof. Zbigniew Śledziński
Gdansk, Poland

Sponsors and Collaborators

Pacira Pharmaceuticals, Inc

Investigators

Principal Investigator:

Zbigniew Śledziński, MD

General Surgery, Transplantology and Endocrinology Department, Gdansk

More Information

No publications provided

Responsible Party:	Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00890721 History of Changes
Other Study ID Numbers:	SKY0402C316
Study First Received:	April 28, 2009
Last Updated:	November 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:

Hemorrhoid
Hemorrhoidectomy

Additional relevant MeSH terms:

Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013