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NCT Number: NCT00974350

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cairns, Queensland, 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

  • 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

Treatment and study plan

SABER-Bupivacaine

Drug

Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once

SABER-Placebo

Drug

Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once

Primary outcomes

  1. Pain Intensity on Movement

    Time frame: 1 to 72 hours post-dose

    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.

  2. Proportion (Percent) of Patients Using Supplemental Opioids

    Time frame: 0 to 14 days post-dose

Secondary outcomes

  1. Pain Intensity

    Time frame: 1 to 48 hours post-dose

    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.

  2. Treatment Satisfaction

    Time frame: 1 to 5 days post-dose

    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).

  3. Supplemental Opioid Use

    Time frame: 0 to 14 days post-dose

  4. Mean Function Activities (Modified Brief Pain Inventory)

    Time frame: 1 to 5 days post-dose

    In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)

Sponsors and collaborators

Lead sponsor

Durect

Industry

Collaborators

  • Nycomed

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 10, 2009
Registry last updated
May 27, 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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