Conditions: Postoperative Pain
Keywords: Postoperative pain Local anaesthesia Postoperative pain after open abdominal hysterectomy surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 115
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: double-blind arm 2: double-blind arm 3: double-blind arm 4: double-blind arm 5: double-blind arm 6: double-blind

Interventions: intervention 1: SABER-Bupivacaine Treatment 1a intervention 2: Placebo SABER-Bupivacaine Treatment 1b intervention 3: Bupivacaine HCl Treatment 1c intervention 4: SABER-Bupivacaine Treatment 2a intervention 5: Placebo SABER-Bupivacaine Treatment 2b intervention 6: Bupivacaine HCl Treatment 2c
Intervention descriptions: intervention 1: 5.0 ml intervention 2: 5.0 ml intervention 3: 40 ml intervention 4: 7.5 ml intervention 5: 7.5 ml intervention 6: 40 ml

Protocol document: