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
Overview
- Phase
- Phase 2
- Intervention
- SABER-Bupivacaine Treatment 1a
- Conditions
- Postoperative Pain
- Sponsor
- Durect
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Pain Intensity (PI)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
SABER-Bupivacaine Treatment 1a
double-blind
Intervention: SABER-Bupivacaine Treatment 1a
Placebo SABER-Bupivacaine Treatment 1b
double-blind
Intervention: Placebo SABER-Bupivacaine Treatment 1b
Bupivacaine HCl Treatment 1c
double-blind
Intervention: Bupivacaine HCl Treatment 1c
SABER-Bupivacaine Treatment 2a
double-blind
Intervention: SABER-Bupivacaine Treatment 2a
Placebo SABER-Bupivacaine Treatment 2b
double-blind
Intervention: Placebo SABER-Bupivacaine Treatment 2b
Bupivacaine HCl Treatment 2c
double-blind
Intervention: Bupivacaine HCl Treatment 2c
Outcomes
Primary Outcomes
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.
Supplemental Opioid Use
Time Frame: 0-3 days after surgery
Cumulative IV morphine-equivalent dose of opioid rescue medication
Secondary Outcomes
- Opioid Related Side Effects(0-7 days after surgery)
- Time to First Opioid Rescue Medication Usage(0-14 days after surgery)