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

This study has been completed.
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Innocoll Technologies
ClinicalTrials.gov Identifier:
NCT01224145
First received: October 18, 2010
Last updated: April 29, 2013
Last verified: October 2011
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Innocoll Technologies:

Primary Outcome Measures:
  • Sum of Pain Intensity (SPI) after aggravated movement (cough) [ Time Frame: through 72 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SPI after aggravated movement (cough) [ Time Frame: through 48 hours after surgery ] [ Designated as safety issue: No ]
  • SPI and individual VAS PI score at rest [ Time Frame: through 72 hours after surgery ] [ Designated as safety issue: No ]
  • Total use of opioid analgesia [ Time Frame: through 72 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: Bupivacaine Collagen Sponge
4, 5x5 bupivacaine collagen sponges
Drug: 4, 5x5cm bupivacaine collagen sponges
Other Name: Bupivacaine collagen implant

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224145

Locations
United States, Texas
Research Concepts
Bellaire, Texas, United States
Sponsors and Collaborators
Innocoll Technologies
Premier Research Group plc
Investigators
Study Director: David Prior Innocoll Technologies
  More Information

Publications:
Responsible Party: Innocoll Technologies
ClinicalTrials.gov Identifier: NCT01224145     History of Changes
Other Study ID Numbers: INN-CB-011
Study First Received: October 18, 2010
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014