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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-02

Study Completion Date

2011-05-18

Brief Summary

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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.

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Detailed Description

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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 recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.

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 from 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 assess pain intensity after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Conditions

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Herniorrhaphy Postoperative Pain Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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2, 5x5cm bupivacaine collagen sponges

collagen sponges

Group Type EXPERIMENTAL

Bupivacaine Collagen Sponge

Intervention Type DRUG

Drug: Bupivacaine Collagen Sponge

2, Placebo collagen sponges

Placebo collagen sponges

Group Type PLACEBO_COMPARATOR

Placebo collagen Sponge

Intervention Type DRUG

Drug: Placebo Collagen Sponge

Interventions

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Bupivacaine Collagen Sponge

Drug: Bupivacaine Collagen Sponge

Intervention Type DRUG

Placebo collagen Sponge

Drug: Placebo Collagen Sponge

Intervention Type DRUG

Other Intervention Names

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Bupivacaine Implant Collagen Implant

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No