Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy

Completed · Phase 2

Conditions studied: Hernia, Postoperative Pain

In brief

This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.

Key facts

Study ID

NCT01224145

Run by

Innocoll

People needed

10

Starts

2011-03-22

Expected to finish

2011-06-20

Last updated by the study team

2020-11-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Concepts — Bellaire, Texas, United States

Full record on ClinicalTrials.gov

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