Status:
COMPLETED
Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
Lead Sponsor:
Innocoll
Collaborating Sponsors:
Premier Research
Conditions:
Herniorrhaphy
Postoperative Pain
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine...
Detailed Description
Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia ...
Eligibility Criteria
Inclusion
- Man ≥ 18 years
- Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.
- Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.
Exclusion
- Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
- Scheduled for bilateral inguinal herniorrhaphy.
- Undergone a prior herniorrhaphy on the side scheduled for repair.
- Undergone major surgery within 3 mos of the scheduled herniorrhaphy.
- Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
- Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
- Used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake.
Key Trial Info
Start Date :
December 2 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01220024
Start Date
December 2 2010
End Date
May 18 2011
Last Update
March 10 2021
Active Locations (1)
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1
Bellaire, Texas, United States, 77401