Study of Pain Control in Hemorrhoidectomy

July 3, 2013 updated by: Pacira Pharmaceuticals, Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdansk, Poland
        • Prof. Zbigniew Śledziński

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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?"
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacira Pharmaceuticals, Inc

Investigators

  • Principal Investigator: Zbigniew Śledziński, MD, General Surgery, Transplantology and Endocrinology Department, Gdansk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (Estimate)

April 30, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKY0402C316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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