Conditions: Postoperative Pain
Keywords: hysterectomy analgesia
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief summary:
The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.

Detailed description:
This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.

Arms:
arm 1: EXPAREL 266 mg diluted with saline to a volume of 40 mL arm 2: EXPAREL 266 mg diluted with saline to a volume of 60 mL

Interventions: intervention 1: EXPAREL
Intervention descriptions: intervention 1: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.

Protocol document: