Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant in Men After Laparoscopic Inguinal or Umbilical 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. Identifier: NCT01224145
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : April 30, 2013
Premier Research Group plc
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Hernia Postoperative Pain Drug: 4, 5x5cm bupivacaine collagen sponges Phase 2

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 laparoscopic placement of synthetic mesh. Studies have shown that the use of synthetic mesh greatly reduces the risk of hernia recurrence regardless of the method used for its placement. Furthermore, utilizing the laparoscopic approach for umbilical hernia repair, specifically with the use of mesh, may also reduce the risk of infection.

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 open-label study will assess pain intensity after surgery in patients who receive the CollaRx Bupivacaine implant as well as determine the feasibility of the use of the laparoscope for sponge placement in laparoscopic hernia repair.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-dose, Open-label Study to Investigate the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Laparoscopic Inguinal or Umbilical Herniorrhaphy
Study Start Date : December 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Drug: Bupivacaine Collagen Sponge
4, 5x5 bupivacaine collagen sponges
Drug: 4, 5x5cm bupivacaine collagen sponges
Other Name: Bupivacaine 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Man ≥18 years
  2. 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.
  3. Willing to use opioid rescue analgesia.

Exclusion Criteria:

  1. Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
  2. Scheduled for bilateral inguinal herniorrhaphy.
  3. Undergone a prior herniorrhaphy at the location scheduled for repair.
  4. Undergone major surgery within 3 months of the scheduled herniorrhaphy.

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 identifier (NCT number): NCT01224145

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

Publications of Results:
Responsible Party: Innocoll Identifier: NCT01224145     History of Changes
Other Study ID Numbers: INN-CB-011
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: April 30, 2013
Last Verified: October 2011

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