Phase 2
N=107
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT00993798 ↗Enrolled (actual)
107
Serious AEs
5.6%
Results posted
Jun 2021
Primary outcome: Primary: Pain Intensity (PI) — 5.16; 6.43; 5.16 score on a scale (time-normalized AUC) — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SABER-Bupivacaine Treatment 1a (Drug); Placebo SABER-Bupivacaine Treatment 1b (Drug); Bupivacaine HCl Treatment 1c (Drug); SABER-Bupivacaine Treatment 2a (Drug); Placebo SABER-Bupivacaine Treatment 2b (Drug); Bupivacaine HCl Treatment 2c (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Durect
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity (PI) |
5.16; 6.43; 5.16 | 0.012 sig |
| PRIMARY Supplemental Opioid Use |
4.0; 12.0; 8.0 | 0.010 sig |
| SECONDARY Time to First Opioid Rescue Medication Usage |
12.4; 1.2; 1.4 | 0.014 sig |
| SECONDARY Opioid Related Side Effects |
0.22; 0.22; 0.25 | 0.773 |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00993798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.