Clinical trial NCT00974350: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Hernia
Surgery
Keywords: Post-operative pain
hernia surgery
opioid
Lead sponsor: Durect
Sponsor class: INDUSTRY
Collaborators: name: Nycomed
First posted: 2009-09-10
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain Intensity on Movement
timeFrame: 1 to 72 hours post-dose
measure: Proportion (Percent) of Patients Using Supplemental Opioids
timeFrame: 0 to 14 days post-dose
Secondary outcomes:
measure: Pain Intensity
timeFrame: 1 to 48 hours post-dose
measure: Treatment Satisfaction
timeFrame: 1 to 5 days post-dose
measure: Supplemental Opioid Use
timeFrame: 0 to 14 days post-dose
measure: Mean Function Activities (Modified Brief Pain Inventory)
timeFrame: 1 to 5 days post-dose
Other outcomes:
Locations:
city: Cairns
country: Australia
state: Queensland
city: Sunnybank
country: Australia
state: Queensland
city: Port Lincoln
country: Australia
state: South Australia
city: Ringwood East
country: Australia
state: Victoria
city: Hamilton
country: New Zealand
Study officials:
affiliation: Durect
name: Dmitri Lissin, MD
role: STUDY_DIRECTOR
References:
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.