Conditions: Hemorrhoids
Keywords: hemorrhoids
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 204
Healthy volunteers: no

Brief summary:
Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Detailed description:
Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Arms:
arm 1: 100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.

A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration. arm 2: 300 mg SKY0402 in a 40-mL injection volume.

A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration.

Interventions: intervention 1: Bupivacaine HCl intervention 2: SKY0402
Intervention descriptions: intervention 1: 100 mg Bupivacaine HCl intervention 2: Single administration 300 mg SKY0402 in a 40-mL injection volume

Protocol document: