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Bupivacaine Effectiveness and Safety in SABER™ Trial (BESST)

This study has been completed.
Sponsor:
Collaborators:
Nycomed
Hospira, Inc.
Information provided by (Responsible Party):
Durect
ClinicalTrials.gov Identifier:
NCT01052012
First received: January 18, 2010
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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 (side effects) associated with the use of SABER™-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.


Condition Intervention Phase
Postoperative Pain
Abdominal Surgery
Drug: SABER™-Bupivacaine
Drug: Bupivacaine HCl
Drug: SABER™-Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupivacaine Effectiveness and Safety in SABER™ Trial (BESST)

Resource links provided by NLM:


Further study details as provided by Durect:

Primary Outcome Measures:
  • Pain intensity on movement [ Time Frame: 0 to 3 days post-dose ] [ Designated as safety issue: No ]
  • Supplemental opioid use [ Time Frame: 0 to 3 days post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean pain intensity on movement [ Time Frame: 0 to 2 days post-dose ] [ Designated as safety issue: No ]
  • Mean total morphine-equivalent dose [ Time Frame: 0 to 2 days post-dose ] [ Designated as safety issue: No ]
  • Proportion of patients who have evidence of a wound infection [ Time Frame: 0 to 14 days post-dose ] [ Designated as safety issue: No ]
  • Time-to-first use of opioid rescue medication [ Time Frame: 0 to 14 days post-dose ] [ Designated as safety issue: No ]
  • Incidence of opioid-related side effects [ Time Frame: 0 to 30 days post-dose ] [ Designated as safety issue: No ]
  • Mean pain intensity at rest during [ Time Frame: 0 to 3 days post-dose ] [ Designated as safety issue: No ]
  • Mean pain intensity at rest [ Time Frame: 0 to 2 days post-dose ] [ Designated as safety issue: No ]
  • Mean scores on the Recovery Index [ Time Frame: 0 to 7 days post-dose ] [ Designated as safety issue: No ]
  • Modified Post-Anesthetic Discharge Scoring System [ Time Frame: 0 to 14 days post-dose ] [ Designated as safety issue: No ]
  • Treatment satisfaction [ Time Frame: 0 to 14 days post-dose ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: December 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active: SABER™-Bupivacaine
SABER™-Bupivacaine
Drug: SABER™-Bupivacaine
Injectable Extended Release Solution; SABER™-Bupivacaine /Once
Active Comparator: Comparator: Bupivacaine HCl
Bupivacaine HCl
Drug: Bupivacaine HCl
Injectable Solution; Bupivacaine HCl /Once
Placebo Comparator: Placebo: SABER™-Placebo
SABER™-Placebo
Drug: SABER™-Placebo
Injectable Solution; SABER™-Placebo/Once

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 years of age and older scheduled to undergo elective general abdominal surgery
  • Patients must be healthy or have only mild systemic diseasePatients must be healthy or have only mild systemic disease
  • BMI < 45
  • Patients must have ECG wave form within normal limits
  • Female and male patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial participation is completed

Exclusion Criteria:

  • Patients who are pregnant or lactating
  • Patients undergoing emergency surgery (unless full consent is obtained and all screening procedures are completed prior to surgery)
  • Significant concomitant surgical procedure
  • History of multiple prior laparotomy procedures
  • Cancer with known metastases pre-operatively, which are suspected to impact post-operative recovery or pain
  • Planned formation of stoma during surgery or plans to undergo another laparotomy procedure within 30 days post-operatively
  • Pre-operative evidence of sepsis or septic shock
  • Pre-operative evaluation that suggests a surgery may preclude full closure of the incision(s)
  • Patients with current or regular use of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications
  • Patients with current or regular use of drugs known to significantly prolong the QTc interval
  • Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g. lidocaine, bupivacaine)
  • Patients with known hypersensitivity to morphine
  • Patients with conditions contraindicated for use of opioids
  • Patients with atrial fibrillation/flutter or other non-sinus rhythm (including paced rhythm); left bundle branch block (LBBB); or the following conditions: right bundle branch block (RBBB) in presence of a cardiac disease, significant cardiomyopathy, and myocardial infarction within last 6 months
  • Patients with a serum creatinine level two times more than the local laboratory normal limit
  • Patients who have received greater than 600 mg morphine equivalent daily dose for three or more days per week in the month prior to the surgical procedure
  • Patients who are currently being treated with methadone, or history of methadone use within the previous 6 months
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052012

  Show 26 Study Locations
Sponsors and Collaborators
Durect
Nycomed
Hospira, Inc.
Investigators
Study Director: Dmitri Lissin, MD Durect Corporation
  More Information

No publications provided

Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT01052012     History of Changes
Other Study ID Numbers: C803-025
Study First Received: January 18, 2010
Last Updated: December 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Durect:
Postoperative pain
Post-operative pain
Opioid
Laparoscopic surgery
Bupivacaine
Local anesthetic

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014