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Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Primary Purpose

Hemorrhoids

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine HCl
SKY0402
Sponsored by
Pacira Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemorrhoids focused on measuring hemorrhoids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Alabama Research Inc.
  • Drug Research and Analysis Corporation
  • Lotus Clinical Research - Huntington Memorial Hospital
  • Accurate Clinical Trials
  • UCSD Medical Center
  • Colon and Rectal Disease Center
  • University of Illinois
  • Indiana University - Wishard Memorial Hospital
  • University of Louisville
  • Montefiore Medical Center
  • Mount Sinai Hospital
  • Duke University Medical Center
  • CTMG, Inc. - Pitt Medical Center
  • Univ. Hospitals of Cleveland, Case Medical Center
  • Holston Medical Group
  • Research Concepts, Ltd
  • Medical Center Ambulatory Surgery Center
  • The Women's Hospital of Texas
  • Roland Saenz
  • Multicare Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Bupivacaine HCl

SKY0402

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
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

Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30

Full Information

First Posted
August 28, 2008
Last Updated
July 3, 2013
Sponsor
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00744848
Brief Title
Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
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 Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacira Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
hemorrhoids

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine HCl
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SKY0402
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl
Other Intervention Name(s)
Marcaine with epinephrine 1:200,000
Intervention Description
100 mg Bupivacaine HCl
Intervention Type
Drug
Intervention Name(s)
SKY0402
Other Intervention Name(s)
DepoBupivacaine
Intervention Description
Single administration 300 mg SKY0402 in a 40-mL injection volume
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
Description
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?"
Time Frame
through 96 hours
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30
Time Frame
through day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kay Warnott, RN, ACN-P
Organizational Affiliation
Pacira Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
West Alabama Research Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Drug Research and Analysis Corporation
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Lotus Clinical Research - Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Accurate Clinical Trials
City
San Clemente
State/Province
California
ZIP/Postal Code
92672
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Colon and Rectal Disease Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
University of Illinois
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62708-0787
Country
United States
Facility Name
Indiana University - Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
CTMG, Inc. - Pitt Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Univ. Hospitals of Cleveland, Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Research Concepts, Ltd
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Medical Center Ambulatory Surgery Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
The Women's Hospital of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Roland Saenz
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Multicare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22900785
Citation
Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
Results Reference
derived

Learn more about this trial

Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

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