Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy

• Status: Completed
• Trial end date: 2008-09-05
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after abdominal hysterectomy surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innocoll
• Collaborator: Premier Research Group plc
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Have a body mass index (BMI) > 19 and < 40 kg/m2

• Had planned an elective total abdominal hysterectomy for reasons other than malignancies to be performed according to standard surgical technique using a standard incision and under general anesthesia with the following caveats:

1. Laparoscopic procedures or supraumbilical or Maylard incisions will not be allowed

2. A nonlaparoscopic incision for benign non-hysterectomy gynecological procedures (such as myomectomy or adnexal surgery) is acceptable if the surgical indication is not to treat pelvic pain

3. No concomitant vaginal procedures are allowed. An abdominal urethropexy and an incidental appendectomy will be allowed

• Have a risk classification of I, II or III according to the American Society of Anesthesiologists (ASA)

• Have a negative pregnancy test

• Be free of other physical or mental conditions which may confound assessment of postoperative pain

• Have the ability to read, understand and comply with the study procedures and the use of the pain scales; is capable of operating a patient-controlled analgesia (PCA) device; and is able to communicate meaningfully with the study staff

• Voluntarily sign and date an informed consent form (ICF), prior to the conduct of any study-specific procedures

• Able to fluently speak and understand English and be able to provide meaningful written informed consent for the study

Exclusion Criteria:

• Known hypersensitivity to any active or inactive ingredient of the test articles

• Presence of clinically significant cardiac arrhythmias or atrioventricular (AV) conduction disorders

• Concomitant use of other amide local anesthetics

• Concomitant use of antiarrhythmics

• Concomitant use of propanolol

• Concomitant use of strong/moderate CYP3A4 inhibitors or inducers

• Has used aspirin or aspirin-containing products within 7 days of surgery.

• Previous major surgery in the last 3 months

• Requires any additional surgical procedures during the same hospitalization (except as noted)

• Received neuraxial (spinal or epidural) opioid analgesics either prior to or during surgery

• Received local anesthetic infiltration of the surgical wound prior to, during or immediately after closure

• Is scheduled to receive local anesthetics via an indwelling catheter after surgery

• Underwent additional procedures during surgery, which may increase the visceral pain

• Has known or suspected history of alcohol or drug abuse or misuse or evidence for tolerance or physical dependency on opioids analgesics or sedative-hypnotic medications

• Uses opioids or tramadol daily for > 7 days prior to test article administration

• Has impaired liver function

• Has any clinically significant unstable condition that could compromise the patient's welfare

• Is at risk for infection or slow wound healing

• Has a chronic painful condition that might confound the assessment of pain associated with the sugery

• Has taken pain medication that could confound the analgesic responses the day of surgery

• Has been treated within 2 weeks of surgery with agents that could affect the analgesic response

• Has been treated with monoamine oxidase inhibitors (MAOIs) or MAOIs have been stopped fewer than 10 days prior to surgery

• Has been treated with corticosteroids or whose treatment with these has been stopped < 7 days prior surgery (inhaled corticosteroids are acceptable)

• Has participated in a clinical trial in the previous 30 days

• Has been hemodynamically unstable at any point in the previous 4 weeks or becomes hemodynamically unstable during surgery

• Required blood transfusion in the previous month, except as related to uterine bleeding caused by uterine fibroids.

• Has hemoglobin levels < 10 g/dL or < 8 g/dL for patients with an anemia secondary to heavy uterine bleeding caused by uterine fibroids.

• Has platelet count < 100,000/mm

• Unreliable or incapable of complying with the protocol