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

This study has been completed.
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Innocoll Technologies
ClinicalTrials.gov Identifier:
NCT00624910
First received: February 19, 2008
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: Bupivacaine Collagen Sponge (CollaRx®)
Drug: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Innocoll Technologies:

Primary Outcome Measures:
  • Total use of opioid rescue analgesia [ Time Frame: 0 to 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total use of opioid rescue analgesia [ Time Frame: 0 to 48 hours postoperatively ] [ Designated as safety issue: No ]
  • Total use of opioid rescue analgesia [ Time Frame: 0 to 72 hours postoperatively ] [ Designated as safety issue: No ]
  • Pain intensity rating on a Visual Analog Scale [ Time Frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively ] [ Designated as safety issue: No ]
  • Pain intensity rating on a 4-point Likert scale [ Time Frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively ] [ Designated as safety issue: No ]
  • Time to first use of opioid rescue analgesia [ Time Frame: Actual time assessed during post operative period ] [ Designated as safety issue: No ]
  • Treatment emergent adverse events [ Time Frame: 0-72 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Vital signs - heart rate, respiration rate, systolic and diastolic blood pressure and body temperature [ Time Frame: 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Drug: Bupivacaine Collagen Sponge (CollaRx®)
The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
Other Name: CollRx Bupivacaine Implant
Placebo Comparator: 2
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
Drug: placebo
The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
No Intervention: 3
The patient will recieve the standard of care, but no implant during surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624910

Locations
United States, North Carolina
Forsyth Medical Centre - OB Anesthesia
Winston Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Innocoll Technologies
Premier Research Group plc
Investigators
Study Director: David Prior Innocoll Technologies
  More Information

No publications provided

Responsible Party: Innocoll Technologies
ClinicalTrials.gov Identifier: NCT00624910     History of Changes
Other Study ID Numbers: INN-CB-002
Study First Received: February 19, 2008
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Innocoll Technologies:
Post Operative Pain
Hysterectomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014