Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy

Completed · Phase 2 · Has a placebo group

Conditions studied: Herniorrhaphy, Postoperative Pain, Inguinal Hernia

In brief

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 implant or a plain collagen sponge.

Key facts

Study ID

NCT01220024

Run by

Innocoll

People needed

50

Starts

2010-12-02

Expected to finish

2011-05-18

Last updated by the study team

2021-03-10

Who can join

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

You may qualify if…

• 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.

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 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.

Where it is running

• Study site — Bellaire, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.