- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224145
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Bellaire, Texas, United States
- Research Concepts
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Man ≥18 years
- 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.
- Willing to use opioid rescue analgesia.
Exclusion Criteria:
- Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
- Scheduled for bilateral inguinal herniorrhaphy.
- Undergone a prior herniorrhaphy at the location scheduled for repair.
- Undergone major surgery within 3 months of the scheduled herniorrhaphy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug: Bupivacaine Collagen Sponge
bupivacaine collagen sponges
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Use of Opioid Analgesia - Morphine Equivalence (mg)
Time Frame: 0 to 24 hours after surgery
|
Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion.
Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary.
The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control.
The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control.
Morphine was the preferred rescue medication.
|
0 to 24 hours after surgery
|
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
Time Frame: 25-48 hours
|
Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion.
Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary.
The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control.
The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control.
Morphine was the preferred rescue medication.
|
25-48 hours
|
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
Time Frame: 49-72 Hours
|
Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion.
Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary.
The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control.
The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control.
Morphine was the preferred rescue medication.
|
49-72 Hours
|
Total Use of Opioid Rescue Analgesia Morphine Equivalence (mg)
Time Frame: 0-48 hours)
|
Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion.
Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary.
The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control.
The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control.
Morphine was the preferred rescue medication.
|
0-48 hours)
|
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
Time Frame: 0-72 hours
|
Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion.
Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary.
The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control.
The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control.
Morphine was the preferred rescue medication.
|
0-72 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INN-CB-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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