Study of Pain Control in Hemorrhoidectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00890721
First received: April 28, 2009
Last updated: July 3, 2013
Last verified: July 2013
  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:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain and respond to the following question: "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"


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.
Other Name: EXPAREL
Placebo Comparator: Placebo
During the hemorrhoidectomy, 30cc Placebo injected into the wound.
Drug: Placebo
During the hemorrhoidectomy, 30cc Placebo injected into the wound.
Other Name: saline 0.9%

  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
  • 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 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: November 22, 2011
Last Updated: July 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
Hemorrhoid
Hemorrhoidectomy
Postoperative pain
Analgesia

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014