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Completed

NCT Number: NCT00818363

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Westmead, New South Wales, 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 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.

Treatment and study plan

SABER-Bupivacaine

Drug

Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once

Other names: POSIMIR® bupivacaine solution

SABER-Placebo

Drug

Injectable Solution; 5.0 mL SABER-Placebo/Once

Primary outcomes

  1. Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.

    Time frame: 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.

  2. Supplemental Opioid Use

    Time frame: 0 to 72 hours post-dose

    Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose

Secondary outcomes

  1. Number (Frequency) of Participants Reporting Opioid-related Adverse Events

    Time frame: 0 to 72 hours post-dose

    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.

  2. Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose).

    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 (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.

  3. Supplemental Opioid Use

    Time frame: 0 to 48 hours post-dose

    Mean total morphine-equivalent dose during the period 0 to 48 hours post-dose (0 to 2 days post-dose)

  4. Time-to-first Use of Opioid Supplemental Pain Medication

    Time frame: 0 to 14 days post-dose

  5. Severity of Opioid-related Side Effects

    Time frame: 0 to 14 days post-dose

Sponsors and collaborators

Lead sponsor

Durect

Industry

Collaborators

  • Nycomed

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 7, 2009
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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