Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
Primary Purpose
Hernia, Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
5x5cm bupivacaine collagen sponges
Sponsored by
About this trial
This is an interventional treatment trial for Hernia
Eligibility Criteria
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.
Sites / Locations
- Research Concepts
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug: Bupivacaine Collagen Sponge
Arm Description
bupivacaine collagen sponges
Outcomes
Primary Outcome Measures
Total Use of Opioid Analgesia - Morphine Equivalence (mg)
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.
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
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.
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
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.
Total Use of Opioid Rescue Analgesia Morphine Equivalence (mg)
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.
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01224145
First Posted
October 18, 2010
Last Updated
November 3, 2020
Sponsor
Innocoll
Collaborators
Premier Research Group plc
1. Study Identification
Unique Protocol Identification Number
NCT01224145
Brief Title
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
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 Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 22, 2011 (Actual)
Primary Completion Date
June 20, 2011 (Actual)
Study Completion Date
June 20, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innocoll
Collaborators
Premier Research Group plc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
laparoscope for bupivacaine sponge (200 mg bupivacaine hydrochloride) placement in laparoscopic hernia repair.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug: Bupivacaine Collagen Sponge
Arm Type
Experimental
Arm Description
bupivacaine collagen sponges
Intervention Type
Drug
Intervention Name(s)
5x5cm bupivacaine collagen sponges
Other Intervention Name(s)
Bupivacaine collagen implant
Primary Outcome Measure Information:
Title
Total Use of Opioid Analgesia - Morphine Equivalence (mg)
Description
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.
Time Frame
0 to 24 hours after surgery
Title
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
Description
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.
Time Frame
25-48 hours
Title
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
Description
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.
Time Frame
49-72 Hours
Title
Total Use of Opioid Rescue Analgesia Morphine Equivalence (mg)
Description
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.
Time Frame
0-48 hours)
Title
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
Description
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.
Time Frame
0-72 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Prior
Organizational Affiliation
Innocoll
Official's Role
Study Director
Facility Information:
Facility Name
Research Concepts
City
Bellaire
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23390367
Citation
Hemsen L, Cusack SL, Minkowitz HS, Kuss ME. A feasibility study to investigate the use of a bupivacaine-collagen implant (XaraColl) for postoperative analgesia following laparoscopic surgery. J Pain Res. 2013;6:79-85. doi: 10.2147/JPR.S40158. Epub 2013 Feb 1.
Results Reference
result
Learn more about this trial
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
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