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

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: Postoperative Pain
• Intervention / Treatment: Drug: SABER-Bupivacaine Treatment 1a; Drug: Placebo SABER-Bupivacaine Treatment 1b; Drug: SABER-Bupivacaine Treatment 2a; Drug: Placebo SABER-Bupivacaine Treatment 2b; Drug: Bupivacaine HCl Treatment 1c; Drug: Bupivacaine HCl Treatment 2c

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

6

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	Cumulative IV morphine-equivalent dose of opioid rescue medication	0-3 days after surgery
Pain Intensity (PI)	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		0-14 days after surgery
Opioid Related Side Effects	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

• Sponsor: Durect
• Collaborators: Nycomed

Study record dates

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: Local anaesthesia; Post operative pain; Postoperative pain after arthroscopic shoulder surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: BU-002-IM