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A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SABER-Bupivacaine
SABER-Placebo
Sponsored by
Durect
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, shoulder surgery, opioid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff.
  • Males and females, 18 to 65 years of age, scheduled for shoulder surgery.
  • Patients must be healthy or have only mild systemic disease.
  • Patients must have ECG wave form within normal limits
  • Patients must have blood pressure within normal range.
  • Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed.
  • Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial.

Exclusion Criteria:

  • Patients with previous arthroscopic surgery or open surgery on the study shoulder.
  • Patients with chronic pain conditions requiring continuous use of corticosteroids for greater than 3 months.
  • Patients with fibromyalgia, rheumatoid arthritis, and/or sero-negative inflammatory arthropathies.
  • Patients with a below normal calculated creatinine clearance.
  • Patients who are pregnant or lactating.
  • Patients currently receiving more than 20 mg of hydrocodone daily (or equivalent narcotic dose) on routine basis.
  • Patients, who in the Investigator's opinion, have developed opioid tolerance.
  • Patients with current or regular use of anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors at screening.
  • Patients with current or regular use of drugs known to significantly prolong the corrected QT interval
  • Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g., lidocaine, bupivacaine).
  • Patients with known hypersensitivity to opioids.
  • Patients with conditions contraindicated for use of opioids.
  • Patients with known or suspected abuse of opioids or other illicit drugs.
  • Patients with known or suspected alcohol abuse.
  • Participation in another clinical trial at the same time or within 30 days of this trial.
  • Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1: SABER-Bupivacaine

Group 2: SABER-Placebo

Arm Description

5.0 mL SABER-Bupivacaine/Once

5.0 mL SABER-Placebo/Once

Outcomes

Primary Outcome Measures

Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.
Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Supplemental Opioid Use
Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose

Secondary Outcome Measures

Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Frequency of subject-reported opioid-related AEs during 0 to 72 hours (0 to 3 days) post-dose and during the trial: constipation, drowsiness, dizziness, nausea, vomiting, respiratory depression, and urinary retention.
Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose).
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose (0 to 2 days post-dose). Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Supplemental Opioid Use
Mean total morphine-equivalent dose during the period 0 to 48 hours post-dose (0 to 2 days post-dose)
Time-to-first Use of Opioid Supplemental Pain Medication
Severity of Opioid-related Side Effects

Full Information

First Posted
January 5, 2009
Last Updated
May 7, 2021
Sponsor
Durect
Collaborators
Nycomed
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1. Study Identification

Unique Protocol Identification Number
NCT00818363
Brief Title
A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery
Official Title
A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER-Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction Following Arthroscopic Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Durect
Collaborators
Nycomed

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, shoulder surgery, opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: SABER-Bupivacaine
Arm Type
Experimental
Arm Description
5.0 mL SABER-Bupivacaine/Once
Arm Title
Group 2: SABER-Placebo
Arm Type
Placebo Comparator
Arm Description
5.0 mL SABER-Placebo/Once
Intervention Type
Drug
Intervention Name(s)
SABER-Bupivacaine
Other Intervention Name(s)
POSIMIR® bupivacaine solution
Intervention Description
Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
Intervention Type
Drug
Intervention Name(s)
SABER-Placebo
Intervention Description
Injectable Solution; 5.0 mL SABER-Placebo/Once
Primary Outcome Measure Information:
Title
Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.
Description
Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Time Frame
0 to 72 hours post-dose
Title
Supplemental Opioid Use
Description
Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose
Time Frame
0 to 72 hours post-dose
Secondary Outcome Measure Information:
Title
Number (Frequency) of Participants Reporting Opioid-related Adverse Events
Description
Frequency of subject-reported opioid-related AEs during 0 to 72 hours (0 to 3 days) post-dose and during the trial: constipation, drowsiness, dizziness, nausea, vomiting, respiratory depression, and urinary retention.
Time Frame
0 to 72 hours post-dose
Title
Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose).
Description
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose (0 to 2 days post-dose). Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Time Frame
0 to 48 hours post-dose
Title
Supplemental Opioid Use
Description
Mean total morphine-equivalent dose during the period 0 to 48 hours post-dose (0 to 2 days post-dose)
Time Frame
0 to 48 hours post-dose
Title
Time-to-first Use of Opioid Supplemental Pain Medication
Time Frame
0 to 14 days post-dose
Title
Severity of Opioid-related Side Effects
Time Frame
0 to 14 days post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff. Males and females, 18 to 65 years of age, scheduled for shoulder surgery. Patients must be healthy or have only mild systemic disease. Patients must have ECG wave form within normal limits Patients must have blood pressure within normal range. Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed. Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial. Exclusion Criteria: Patients with previous arthroscopic surgery or open surgery on the study shoulder. Patients with chronic pain conditions requiring continuous use of corticosteroids for greater than 3 months. Patients with fibromyalgia, rheumatoid arthritis, and/or sero-negative inflammatory arthropathies. Patients with a below normal calculated creatinine clearance. Patients who are pregnant or lactating. Patients currently receiving more than 20 mg of hydrocodone daily (or equivalent narcotic dose) on routine basis. Patients, who in the Investigator's opinion, have developed opioid tolerance. Patients with current or regular use of anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors at screening. Patients with current or regular use of drugs known to significantly prolong the corrected QT interval Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g., lidocaine, bupivacaine). Patients with known hypersensitivity to opioids. Patients with conditions contraindicated for use of opioids. Patients with known or suspected abuse of opioids or other illicit drugs. Patients with known or suspected alcohol abuse. Participation in another clinical trial at the same time or within 30 days of this trial. Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitri Lissin, MD
Organizational Affiliation
Durect
Official's Role
Study Director
Facility Information:
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
City
Toorak Gardens
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
City
Hampton
State/Province
Victoria
ZIP/Postal Code
3188
Country
Australia
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
City
Christchurch
Country
New Zealand
City
Hamilton
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
22510183
Citation
Hadj A, Hadj A, Hadj A, Rosenfeldt F, Nicholson D, Moodie J, Turner R, Watts R, Fletcher I, Abrouk N, Lissin D. Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial. ANZ J Surg. 2012 Apr;82(4):251-7. doi: 10.1111/j.1445-2197.2011.05754.x. Epub 2011 Jun 24.
Results Reference
derived

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A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery

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