Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Pacira

Status and phase: Completed; Phase 3

Conditions: Hemorrhoids

Treatments: Drug: Bupivacaine HCl; Drug: SKY0402

Study type: Interventional

Funder types: Industry

Identifiers

NCT00744848

SIMPLE Hemorrhoidectomy 312

Details and patient eligibility

About

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

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female equal or greater than 18 years of age at Screening
• Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy.
• Scheduled to undergo 2-or3-column excisional hemorrhoidectomy
• American Society of Anesthesiology (ASA) Physical Class 1-4
• Able and willing to complete with all study visits and procedures
• Able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments
• Willing and capable of provide written informed consent.

Exclusion criteria

• Pregnant, nursing or planning to become pregnant during the study period
• Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery.
• Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments.
• Single-column hemorrhoidectomy
• Body weight less than 50 kg (110 pounds)
• History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in Marcaine with epinephrine)
• contraindication to epinephrine
• contraindication to any of the pain-control agents planned for postoperative use
• Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration
• History of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years.
• Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance.
• Significant medical conditions or laboratory results that indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial.
• Any clinically significant event or condition uncovered during surgery
• A cumulative incision length less than 3 cm

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups

Bupivacaine HCl

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine HCl

SKY0402

Other group

Description:

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.

Treatment:

Drug: SKY0402