Status:
COMPLETED
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
Lead Sponsor:
Innocoll
Collaborating Sponsors:
Premier Research
Conditions:
Hernia
Postoperative Pain
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.
Detailed Description
Inguinal herniorrhaphy is a common surgery; approximately 2,800 per million people in the United States (US) undergo the procedure annually.Common surgical methods of herniorrhaphy include open and la...
Eligibility Criteria
Inclusion
- Man ≥18 years
- Has a planned unilateral inguinal herniorrhaphy (laparoscopy, transabdominal preperitoneal \[TAPP\] approach or totally extraperitoneal \[TEP\] approach) or laparoscopic umbilical herniorrhaphy to be performed according to standard surgical technique under general anesthesia.
- Willing to use opioid rescue analgesia.
Exclusion
- Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
- Scheduled for bilateral inguinal herniorrhaphy.
- Undergone a prior herniorrhaphy at the location scheduled for repair.
- Undergone major surgery within 3 months of the scheduled herniorrhaphy.
Key Trial Info
Start Date :
March 22 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01224145
Start Date
March 22 2011
End Date
June 20 2011
Last Update
November 4 2020
Active Locations (1)
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1
Research Concepts
Bellaire, Texas, United States