Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery
Drug: Bupivacaine Collagen Sponge
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase II, Randomized, Single-dose, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Pharmacokinetic Profile of the CollaRx Bupivacaine Implant in Patients After Gastrointestinal Surgery|
- The total amount of opioid rescue analgesia used [ Time Frame: 0 to 24 hours postoperatively ]
- The total amount of opioid rescue analgesia used [ Time Frame: 0 to 48 hours postoperatively ]
- The total amount of opioid rescue analgesia used [ Time Frame: 0 to 72 hours postoperatively ]
- Pain intensity rating on the Visual Analogue Scale (VAS) [ Time Frame: 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 ]
- Pain intensity rating on a 4-point scale [ Time Frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively ]
- Pain relief rating on a 5-point scale [ Time Frame: At 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 ]
- Patient global evaluation of study treatment on a 5-point scale [ Time Frame: At 72 hours after time 0 ]
- Time to first use of opioid rescue analgesia [ Time Frame: actual time from time 0 ]
- Pharmacokinetic parameters [ Time Frame: 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively ]
- The incidence of treatment-emergent Adverse Events [ Time Frame: Through 30 days after surgery ]
- Changes in vital sign measurements [ Time Frame: Through 72 hours post insertion ]
|Study Start Date:||April 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
|Drug: Bupivacaine Collagen Sponge|
Placebo Comparator: 2
Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
Gastrointestinal (GI) surgery encompasses a range of surgical procedures that involve abdominal incision. Gastrointestinal surgery may be performed to treat an abdominal aortic aneurysm, ulcerative colitis, Crohn's disease, gallbladder disease, bile duct disease and morbid obesity. Although less invasive laparoscopic procedures are performed when warranted, open abdominal surgery is required for certain indications and for more complicated or advanced cases.
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 for 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 or a plain collagen sponge.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661466
|United States, New York|
|Albany Medical Center Hospital|
|Albany, New York, United States, 12208|
|Study Director:||David Prior||Innocoll|