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Completed

NCT Number: NCT01052012

Bupivacaine Effectiveness and Safety in SABER® Trial

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.

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Key information

Conditions

Postoperative Pain Abdominal Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DURECT Study Site, Woodville South, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

SABER-Bupivacaine

Drug

Injectable Extended Release Solution; SABER-Bupivacaine /Once

Other names: POSIMIR® bupivacaine solution

Bupivacaine HCl

Drug

Injectable Solution; Bupivacaine HCl /Once

SABER-Placebo

Drug

Injectable Solution; SABER-Placebo/Once

Primary outcomes

  1. Mean Pain Intensity on Movement

    Time frame: 0 to 72 hours post-dose

    Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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.

  2. Supplemental Opioid Use

    Time frame: 0-72 hours post dose

    Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.

Secondary outcomes

  1. Mean Pain Intensity on Movement

    Time frame: 0 to 48 hours post-dose

    Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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.

  2. Total Morphine-equivalent Dose

    Time frame: 0-48 hours post dose

    Total morphine-equivalent dose during 0-48 hours post dose.

  3. Proportion (Percent) of Patients Who Have Evidence of a Wound Infection

    Time frame: 0 to 14 days post-dose (Visits 3 and 4)

    From Surgical Wound Healing and Local Tissue Condition Evaluation

  4. Time-to-first Use of Opioid Rescue Medication

    Time frame: 0 to 14 days post-dose (Time from extubation until first opioid use)

  5. Number (Incidence) of Participants With Opioid-related Side Effects

    Time frame: 0 to 30 days post-dose

    AEs include: nausea, vomiting, constipation, dizziness, somnolence, urinary retention, respiratory depression

  6. Pain Intensity at Rest AUC During 0-72 Hours Post Dose

    Time frame: 0-72 hours post dose

    Mean pain intensity at rest AUC during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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.

  7. Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose

    Time frame: 0-48 hours post dose

    Mean pain intensity at rest AUC during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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.

Sponsors and collaborators

Lead sponsor

Durect

Industry

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer
  • Nycomed

Registry information

Official study title

Bupivacaine Effectiveness and Safety in SABER Trial (BESST)

Acronym: BESST

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 20, 2010
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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