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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01220024
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : September 4, 2014
Premier Research Group plc
Information provided by (Responsible Party):

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 implant or a plain collagen sponge.

Condition or disease Intervention/treatment Phase
Herniorrhaphy Postoperative Pain Inguinal Hernia Drug: Bupivacaine Collagen Sponge Drug: Placebo collagen Sponge Phase 2

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Single Dose, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety Profile of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Open Laparotomy Herniorrhaphy
Study Start Date : December 2010
Primary Completion Date : June 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 2, 5x5cm bupivacaine collagen sponges Drug: Bupivacaine Collagen Sponge
Drug: Bupivacaine Collagen Sponge
Other Name: Bupivacaine Implant
Placebo Comparator: 2, Placebo collagen sponges Drug: Placebo collagen Sponge
Drug: Placebo Collagen Sponge
Other Name: Collagen Implant

Primary Outcome Measures :
  1. Sum of pain intensity (SPI) after aggravated movement (cough) [ Time Frame: through 72 hours after surgery ]

Secondary Outcome Measures :
  1. SPI after aggravated movement (cough) [ Time Frame: through 48 hours after surgery ]
  2. SPI and individual VAS PI score at rest [ Time Frame: through 72 hours after surgery ]
  3. Total use of opioid analgesia [ Time Frame: through 72 hours after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220024

United States, Texas
Bellaire, Texas, United States
Sponsors and Collaborators
Premier Research Group plc
Study Director: David Prior Innocoll

Responsible Party: Innocoll
ClinicalTrials.gov Identifier: NCT01220024     History of Changes
Other Study ID Numbers: INN-CB-010
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: April 2013

Additional relevant MeSH terms:
Pain, Postoperative
Hernia, Inguinal
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Hernia, Abdominal
Pathological Conditions, Anatomical
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents