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

This study has been completed.
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Innocoll Technologies
ClinicalTrials.gov Identifier:
NCT01220024
First received: September 23, 2010
Last updated: September 2, 2014
Last verified: April 2013
  Purpose

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 Intervention Phase
Herniorrhaphy
Postoperative Pain
Inguinal Hernia
Drug: Bupivacaine Collagen Sponge
Drug: Placebo collagen Sponge
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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: 50
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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.
  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: NCT01220024

Locations
United States, Texas
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: NCT01220024     History of Changes
Other Study ID Numbers: INN-CB-010
Study First Received: September 23, 2010
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014