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Study of Pain Control in Hemorrhoidectomy

Primary Purpose

Hemorrhoid

Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
SKY0402
Placebo
Sponsored by
Pacira Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoid focused on measuring Hemorrhoid, Hemorrhoidectomy, Postoperative pain, Analgesia

Eligibility Criteria

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

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

Sites / Locations

  • Prof. Zbigniew Śledziński

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SKY0402

Placebo

Arm Description

During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.

During the hemorrhoidectomy, 30cc Placebo injected into the wound.

Outcomes

Primary Outcome Measures

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.
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?"

Secondary Outcome Measures

Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days

Full Information

First Posted
April 28, 2009
Last Updated
July 3, 2013
Sponsor
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00890721
Brief Title
Study of Pain Control in Hemorrhoidectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 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
Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoid
Keywords
Hemorrhoid, Hemorrhoidectomy, Postoperative pain, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SKY0402
Arm Type
Experimental
Arm Description
During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During the hemorrhoidectomy, 30cc Placebo injected into the wound.
Intervention Type
Drug
Intervention Name(s)
SKY0402
Other Intervention Name(s)
EXPAREL
Intervention Description
During the operation, 30cc of SKY0402 are injected into the wound.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline 0.9%
Intervention Description
During the hemorrhoidectomy, 30cc Placebo injected into the wound.
Primary Outcome Measure Information:
Title
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.
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 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?"
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zbigniew Śledziński, MD
Organizational Affiliation
General Surgery, Transplantology and Endocrinology Department, Gdansk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Zbigniew Śledziński
City
Gdansk
Country
Poland

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

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Study of Pain Control in Hemorrhoidectomy

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