The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
7
placebo
Albany Medical Center Hospital
Albany, New York, United States
The Total Amount of Opioid Rescue Analgesia Used
Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Time frame: 0 to 24 hours postoperatively
The Total Amount of Opioid Rescue Analgesia Used
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Time frame: 0 to 48 hours postoperatively
The Total Amount of Opioid Rescue Analgesia Used
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Time frame: 0 to 72 hours postoperatively
Pain Intensity Rating on the Visual Analogue Scale (VAS)
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
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
Study Terminated Early - Secondary end point not measured - not done
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
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
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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
Study Terminated Early - Secondary end point not measured - not done
Time frame: At 72 hours after time 0
Time to First Use of Opioid Rescue Analgesia
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Time frame: actual time from time 0
Pharmacokinetic Parameters
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
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
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Time frame: Through 30 days after surgery
Changes in Vital Sign Measurements
Study Terminated Early - Secondary end point not measured - not done - Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Time frame: Through 72 hours post insertion