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 Undergoing Primary, Elective, Open, Abdominal Hysterectomy
Overview
- Phase
- Phase 2
- Intervention
- SABER-Bupivacaine Treatment 1a
- Conditions
- Postoperative Pain
- Sponsor
- Durect
- Enrollment
- 115
- 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 hysterectomy 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 the efficacy and safety of the product.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A planned elective, abdominal hysterectomy
- •Patients suitable for general anaesthesia
Exclusion Criteria
- •Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
- •Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances. History of cured localised malignancies is allowed (i.e. basal or squamous cell skin carcinoma, breast carcinoma or cervical carcinoma)
- •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: 1 to 72 hours post-surgery
Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS 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.
Supplemental Opioid Use
Time Frame: 0-3 days after surgery
Cumulative IV morphine-equivalent dose of opioid rescue medication
Secondary Outcomes
- Time to First Opioid Rescue Medication Usage(0-14 days after surgery)
- Opioid Related Side Effects(0-7 days after surgery)