Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

July 3, 2013 updated by: Pacira Pharmaceuticals, Inc

Phase 3, Multicenter, Randomized, Double-Blind, Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Study Type

Interventional

Enrollment (Actual)

204

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • West Alabama Research Inc.
      • Montgomery, Alabama, United States, 36106
        • Drug Research and Analysis Corporation
    • California
      • Pasadena, California, United States, 91105
        • Lotus Clinical Research - Huntington Memorial Hospital
      • San Clemente, California, United States, 92672
        • Accurate Clinical Trials
      • San Diego, California, United States, 92121
        • UCSD Medical Center
    • Florida
      • Orlando, Florida, United States, 32804
        • Colon and Rectal Disease Center
    • Illinois
      • Springfield, Illinois, United States, 62708-0787
        • University of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University - Wishard Memorial Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27834
        • CTMG, Inc. - Pitt Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ. Hospitals of Cleveland, Case Medical Center
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
    • Texas
      • Bellaire, Texas, United States, 77401
        • Research Concepts, Ltd
      • Houston, Texas, United States, 77054
        • The Women's Hospital of Texas
      • Houston, Texas, United States, 77054
        • Medical Center Ambulatory Surgery Center
      • San Antonio, Texas, United States, 78205
        • Roland Saenz
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System

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:

  • Male or female equal or greater than 18 years of age at Screening
  • Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy.
  • Scheduled to undergo 2-or3-column excisional hemorrhoidectomy
  • American Society of Anesthesiology (ASA) Physical Class 1-4
  • Able and willing to complete with all study visits and procedures
  • Able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments
  • Willing and capable of provide written informed consent.

Exclusion Criteria:

  • Pregnant, nursing or planning to become pregnant during the study period
  • Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery.
  • Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments.
  • Single-column hemorrhoidectomy
  • Body weight less than 50 kg (110 pounds)
  • History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in Marcaine with epinephrine)
  • contraindication to epinephrine
  • contraindication to any of the pain-control agents planned for postoperative use
  • Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration
  • History of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years.
  • Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance.
  • Significant medical conditions or laboratory results that indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial.
  • Any clinically significant event or condition uncovered during surgery
  • A cumulative incision length less than 3 cm

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine HCl

100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.

A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration.
Drug: Bupivacaine HCl
100 mg Bupivacaine HCl
Other Names:
  • Marcaine with epinephrine 1:200,000
Other: SKY0402

300 mg SKY0402 in a 40-mL injection volume.

A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration.
Drug: SKY0402
Single administration 300 mg SKY0402 in a 40-mL injection volume
Other Names:
  • DepoBupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
Time Frame: through 96 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. The subject was to rest in this position for at least 5 minutes before responding 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?"
through 96 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30
Time Frame: through day 30
through day 30

Collaborators and Investigators

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

Sponsor

Pacira Pharmaceuticals, Inc

Investigators

  • Study Director: Kay Warnott, RN, ACN-P, Pacira Pharmaceuticals, Inc

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

August 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

August 28, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

September 1, 2008

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

  • SIMPLE Hemorrhoidectomy 312

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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