Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
- Registration Number
- NCT00744848
- Lead Sponsor
- Pacira Pharmaceuticals, Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SKY0402 SKY0402 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. Bupivacaine HCl Bupivacaine HCl 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.
- Primary Outcome Measures
Name Time Method Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores through 96 hours To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30 through day 30
Trial Locations
- Locations (20)
University of Louisville
🇺🇸Louisville, Kentucky, United States
West Alabama Research Inc.
🇺🇸Birmingham, Alabama, United States
Accurate Clinical Trials
🇺🇸San Clemente, California, United States
Colon and Rectal Disease Center
🇺🇸Orlando, Florida, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
UCSD Medical Center
🇺🇸San Diego, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Illinois
🇺🇸Springfield, Illinois, United States
Indiana University - Wishard Memorial Hospital
🇺🇸Indianapolis, Indiana, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
CTMG, Inc. - Pitt Medical Center
🇺🇸Greenville, North Carolina, United States
Research Concepts, Ltd
🇺🇸Bellaire, Texas, United States
Multicare Health System
🇺🇸Tacoma, Washington, United States
The Women's Hospital of Texas
🇺🇸Houston, Texas, United States
Lotus Clinical Research - Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
Univ. Hospitals of Cleveland, Case Medical Center
🇺🇸Cleveland, Ohio, United States
Drug Research and Analysis Corporation
🇺🇸Montgomery, Alabama, United States
Medical Center Ambulatory Surgery Center
🇺🇸Houston, Texas, United States
Roland Saenz
🇺🇸San Antonio, Texas, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States