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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.
 
ClinicalTrials.gov Identifier: NCT00744848
Recruitment Status : Completed
First Posted : September 1, 2008
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Sponsor:
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.

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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

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 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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00744848


Locations
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Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
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Study Director: Kay Warnott, RN, ACN-P Pacira Pharmaceuticals, Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00744848    
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:
hemorrhoids
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Epinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
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
Mydriatics
Sympathomimetics
Vasoconstrictor Agents