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A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair

Primary Purpose

Postoperative Pain, Hernia, Surgery

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SABER-Bupivacaine
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 Post-operative pain, hernia surgery, opioid

Eligibility Criteria

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

Inclusion Criteria:

  • Males and females, 18 to 65 years of age, scheduled for hernia repair surgery
  • Patients must be in good health prior to study participation
  • Patients must have blood pressure within normal range or with Stage 1 high blood pressure
  • 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
  • Ability to read, understand, communicate, and voluntarily sign the informed consent form prior to any trial specific procedures

Exclusion Criteria:

  • Patients with previous abdominal surgery scar tissue
  • Patients with clinically significant abnormalities of any body system unrelated to the disease under study
  • Connective tissue disorders
  • Patients who are pregnant or lactating
  • Current or regular use of analgesic medication for other indications
  • Patients with current or regular use of antidepressants or monoamine oxidase inhibitors at screening
  • Use of any drugs or medication that may interfere with the study and its results
  • Patients with known hypersensitivity to the study drugs or their components
  • Patients with known or suspected alcohol abuse or illicit drug use
  • Participation in another clinical trial at the same time or within 30 days of this trial
  • Patient is unwilling to comply with the study procedures

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1: SABER-Bupivacaine

Group 2: SABER-Bupivacaine

Group 3: SABER-Placebo

Arm Description

2.5 mL SABER-Bupivacaine/Once

5.0 mL SABER-Bupivacaine/Once

2.5 mL or 5.0 mL SABER-Placebo/Once

Outcomes

Primary Outcome Measures

Pain Intensity on Movement
Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Proportion (Percent) of Patients Using Supplemental Opioids

Secondary Outcome Measures

Pain Intensity
Pain intensity AUC over the time period of 1 to 48 hours. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Treatment Satisfaction
Modified Brief Pain Inventory -An overall assessment of treatment satisfaction was made using 6 point verbal rating scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied).
Supplemental Opioid Use
Mean Function Activities (Modified Brief Pain Inventory)
In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)

Full Information

First Posted
September 8, 2009
Last Updated
May 5, 2021
Sponsor
Durect
Collaborators
Nycomed
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1. Study Identification

Unique Protocol Identification Number
NCT00974350
Brief Title
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
Official Title
A Double-Blind, Placebo-Controlled, Pharmacodynamic and Pharmacokinetic Dose Response Study of SABER-Bupivacaine Instilled Into the Wound in Patients Undergoing Open Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

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. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia. The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Hernia, Surgery
Keywords
Post-operative pain, hernia surgery, opioid

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1: SABER-Bupivacaine
Arm Type
Experimental
Arm Description
2.5 mL SABER-Bupivacaine/Once
Arm Title
Group 2: SABER-Bupivacaine
Arm Type
Experimental
Arm Description
5.0 mL SABER-Bupivacaine/Once
Arm Title
Group 3: SABER-Placebo
Arm Type
Placebo Comparator
Arm Description
2.5 mL or 5.0 mL SABER-Placebo/Once
Intervention Type
Drug
Intervention Name(s)
SABER-Bupivacaine
Intervention Description
Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/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; 2.5 or 5.0 mL SABER-Placebo/Once
Primary Outcome Measure Information:
Title
Pain Intensity on Movement
Description
Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Time Frame
1 to 72 hours post-dose
Title
Proportion (Percent) of Patients Using Supplemental Opioids
Time Frame
0 to 14 days post-dose
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity AUC over the time period of 1 to 48 hours. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Time Frame
1 to 48 hours post-dose
Title
Treatment Satisfaction
Description
Modified Brief Pain Inventory -An overall assessment of treatment satisfaction was made using 6 point verbal rating scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied).
Time Frame
1 to 5 days post-dose
Title
Supplemental Opioid Use
Time Frame
0 to 14 days post-dose
Title
Mean Function Activities (Modified Brief Pain Inventory)
Description
In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)
Time Frame
1 to 5 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: Males and females, 18 to 65 years of age, scheduled for hernia repair surgery Patients must be in good health prior to study participation Patients must have blood pressure within normal range or with Stage 1 high blood pressure 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 Ability to read, understand, communicate, and voluntarily sign the informed consent form prior to any trial specific procedures Exclusion Criteria: Patients with previous abdominal surgery scar tissue Patients with clinically significant abnormalities of any body system unrelated to the disease under study Connective tissue disorders Patients who are pregnant or lactating Current or regular use of analgesic medication for other indications Patients with current or regular use of antidepressants or monoamine oxidase inhibitors at screening Use of any drugs or medication that may interfere with the study and its results Patients with known hypersensitivity to the study drugs or their components Patients with known or suspected alcohol abuse or illicit drug use Participation in another clinical trial at the same time or within 30 days of this trial Patient is unwilling to comply with the study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitri Lissin, MD
Organizational Affiliation
Durect
Official's Role
Study Director
Facility Information:
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
City
Sunnybank
State/Province
Queensland
ZIP/Postal Code
4109
Country
Australia
City
Port Lincoln
State/Province
South Australia
ZIP/Postal Code
5606
Country
Australia
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
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
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A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair

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