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

Information source: Innocoll
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: Bupivacaine Collagen Sponge (CollaRx®) (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Innocoll

Official(s) and/or principal investigator(s):
David Prior, Study Director, Affiliation: Innocoll


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.

Clinical Details

Official title: A Phase II, Single Dose, Blinded, Prospective Study to Investigate the Efficacy and Safety of the CollaRx® Bupivacaine Implant in Women Following Abdominal Hysterectomy or Other Nonlaparoscopic Benign Gynecological Procedure

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Total use of opioid rescue analgesia

Secondary outcome:

Total use of opioid rescue analgesia

Total use of opioid rescue analgesia

Pain intensity rating on a Visual Analog Scale

Pain intensity rating on a 4-point Likert scale

Time to first use of opioid rescue analgesia

Treatment emergent adverse events

Vital signs - heart rate, respiration rate, systolic and diastolic blood pressure and body temperature

Detailed description: Hysterectomy is the second most common surgery among women in the United States (US). According to the National Center for Health Statistics, there were 617,000 hysterectomies performed in the US in 2004. Effective postoperative pain management after hysterectomy is important in ensuring that surgical subjects have a smooth and successful recovery after their operation. Morphine and other narcotic pain medications are often used to help control pain after hysterectomy, but the large quantities required can lead to fatigue, nausea and vomiting, as well as the inability to walk around much because of drowsiness. Reducing narcotic pain medication use can reduce these negative side effects. Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery. This study will compare the amount of narcotic pain medication required after surgery in patients who receive the CollaRx Bupivacaine implant, a plain collagen implant or no implant at all.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.


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


- 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


- 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


- 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

Locations and Contacts

Forsyth Medical Centre - OB Anesthesia, Winston Salem, North Carolina 27103, United States
Additional Information

Starting date: December 2007
Last updated: March 22, 2012

Page last updated: August 23, 2015

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