Study of Pain Control in Hemorrhoidectomy

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

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
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%


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

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
Please refer to this study by its identifier: NCT00890721

Prof. Zbigniew Śledziński
Gdansk, Poland
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Principal Investigator: Zbigniew Śledziński, MD General Surgery, Transplantology and Endocrinology Department, Gdansk
  More Information

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc 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:
Postoperative pain

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on April 15, 2014