Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00744848
Recruitment Status : Completed
First Posted : September 1, 2008
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
Hemorrhoids Drug: Bupivacaine HCl Drug: SKY0402 Phase 3

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  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : August 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

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 Name: Marcaine with epinephrine 1:200,000


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 Name: DepoBupivacaine

Primary Outcome Measures :
  1. 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?"

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30 [ Time Frame: through day 30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00744848

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pacira Pharmaceuticals, Inc Identifier: NCT00744848     History of Changes
Other Study ID Numbers: SIMPLE Hemorrhoidectomy 312
First Posted: September 1, 2008    Key Record Dates
Results First Posted: August 6, 2013
Last Update Posted: August 6, 2013
Last Verified: July 2013

Keywords provided by Pacira Pharmaceuticals, Inc:

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents