An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery

May 13, 2021 updated by: Durect

An International, Randomised, Double Blinded, Multi-centre, Active- and Placebo-controlled Dose Response Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery

The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Nycomed Investigational Site
      • Vienna, Austria, 1090
        • Nycomed Investigational Site
      • Vienna, Austria, 1130
        • Nycomed Investigational Site
  • Germany
      • Berlin, Germany
        • Nycomed Investigational Site
      • Dresden, Germany
        • Nycomed Investigational Site
      • Marburg, Germany
        • Nycomed Investigational Site
  • Latvia
      • Riga, Latvia
        • Nycomed Investigational Site
      • Valmiera, Latvia
        • Nycomed Investigational Site
  • Poland
      • Lodz, Poland
        • Nycomed Investigational Site
  • Sweden
      • Stockholm, Sweden
        • Nycomed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subacromial impingement syndrome
  • MRI with intact rotator cuff
  • Patients suitable for general anaesthesia

Exclusion Criteria:

  • Known major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, glenohumeral arthritis, frozen shoulder or previous surgery of the affected shoulder
  • Abnormal ECG
  • Prolonged QT syndrome
  • Current or regular use of analgesic medication for other indication(s)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SABER-Bupivacaine Treatment 1a
double-blind
Drug: SABER-Bupivacaine Treatment 1a
5.0 ml
Other Names:
  • POSIMIR® bupivacaine solution
Placebo Comparator: Placebo SABER-Bupivacaine Treatment 1b
double-blind
Drug: Placebo SABER-Bupivacaine Treatment 1b
5.0 ml
Active Comparator: Bupivacaine HCl Treatment 1c
double-blind
Drug: Bupivacaine HCl Treatment 1c
20.0 ml
Experimental: SABER-Bupivacaine Treatment 2a
double-blind
Drug: SABER-Bupivacaine Treatment 2a
7.5 ml
Placebo Comparator: Placebo SABER-Bupivacaine Treatment 2b
double-blind
Drug: Placebo SABER-Bupivacaine Treatment 2b
7.5 ml
Active Comparator: Bupivacaine HCl Treatment 2c
double-blind
Drug: Bupivacaine HCl Treatment 2c
20.0 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Supplemental Opioid Use
Time Frame: 0-3 days after surgery
Cumulative IV morphine-equivalent dose of opioid rescue medication
0-3 days after surgery
Pain Intensity (PI)
Time Frame: 0-3 days after surgery
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0-3 days after surgery. 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.
0-3 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Opioid Rescue Medication Usage
Time Frame: 0-14 days after surgery
0-14 days after surgery
Opioid Related Side Effects
Time Frame: 0-7 days after surgery

Opioid-related side effects were recorded 0-7 days after surgery. The Opioid-Related Symptom Distress Scale (OR-SDS) is a composite score computed from a questionnaire containing frequent opioid-related symptoms (Fatigue, Drowsiness, Inability to concentrate, Nausea, Dizziness, Constipation, Itching, Difficulty with urination, Confusion, Retching/vomiting). For each symptom, patients assigned integer scores to assess severity (none=0 to very severe=4), bothersomeness (none=0 to very much=5), and frequency (none=0 to almost constantly=4); patients reported number of Retching/vomiting episodes (none=0, 1-2 episodes=1, 3-4 episodes=2, 5-6 episodes=3, >6 episodes=4).

On each day (Day 0-7), the score for each symptom was the mean of the three component scores, and the OR-SDS score was the overall mean of the 10 symptom scores, (values from 0 to 4; larger outcomes are worse). The mean of the daily OR-SDS score from Day 0 to 7 gave the overall OR-SDS Score.
0-7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Durect

Collaborators

Nycomed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 9, 2009

First Submitted That Met QC Criteria

October 9, 2009

First Posted (Estimate)

October 12, 2009

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BU-002-IM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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