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

Primary Purpose

Herniorrhaphy, Postoperative Pain, Inguinal Hernia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine Collagen Sponge
Placebo collagen Sponge
Sponsored by
Innocoll
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herniorrhaphy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2, 5x5cm bupivacaine collagen sponges

2, Placebo collagen sponges

Arm Description

collagen sponges

Placebo collagen sponges

Outcomes

Primary Outcome Measures

Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores.
The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported.

Secondary Outcome Measures

Sum of Pain Intensity (SPI) After Aggravated Movement (Cough)
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period.
Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period.
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough)
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. The lower the sore the better the outcome. Higher score is a worse outcome
Pain Intensity VAS Scores Over Time at Rest
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. Lower score is better. Higher score means more pain. Time points are summarized independently
Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) for each timepoint. (timepoints 1,2,4,6,8,10,12,24,48 and 72 hours ) Patients were asked during multiple time points to provide a score on this VAS scale. For 1 to 24 hours the highest score possible would be 800. For 1 to 48 hours the highest score possible would be 900. For 1 to 72 hours the highest score possible would be 1000. A mean Lower score is better. A mean Higher score is a worse outcome.

Full Information

First Posted
September 23, 2010
Last Updated
February 18, 2021
Sponsor
Innocoll
Collaborators
Premier Research Group plc
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1. Study Identification

Unique Protocol Identification Number
NCT01220024
Brief Title
Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 2, 2010 (Actual)
Primary Completion Date
May 18, 2011 (Actual)
Study Completion Date
May 18, 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 after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herniorrhaphy, Postoperative Pain, Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2, 5x5cm bupivacaine collagen sponges
Arm Type
Experimental
Arm Description
collagen sponges
Arm Title
2, Placebo collagen sponges
Arm Type
Placebo Comparator
Arm Description
Placebo collagen sponges
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Collagen Sponge
Other Intervention Name(s)
Bupivacaine Implant
Intervention Description
Drug: Bupivacaine Collagen Sponge
Intervention Type
Drug
Intervention Name(s)
Placebo collagen Sponge
Other Intervention Name(s)
Collagen Implant
Intervention Description
Drug: Placebo Collagen Sponge
Primary Outcome Measure Information:
Title
Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores.
Description
The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported.
Time Frame
1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Secondary Outcome Measure Information:
Title
Sum of Pain Intensity (SPI) After Aggravated Movement (Cough)
Description
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period.
Time Frame
1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Title
Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest
Description
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period.
Time Frame
1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Title
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough)
Description
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. The lower the sore the better the outcome. Higher score is a worse outcome
Time Frame
1,2,4,6,8,10,12,24,48 and 72 hours
Title
Pain Intensity VAS Scores Over Time at Rest
Description
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. Lower score is better. Higher score means more pain. Time points are summarized independently
Time Frame
1,2,4,6,8,10,12,24,48 and 72 hours
Title
Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement
Description
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) for each timepoint. (timepoints 1,2,4,6,8,10,12,24,48 and 72 hours ) Patients were asked during multiple time points to provide a score on this VAS scale. For 1 to 24 hours the highest score possible would be 800. For 1 to 48 hours the highest score possible would be 900. For 1 to 72 hours the highest score possible would be 1000. A mean Lower score is better. A mean Higher score is a worse outcome.
Time Frame
1,2,4,6,8,10,12,24,48 and 72 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Prior
Organizational Affiliation
Innocoll
Official's Role
Study Director
Facility Information:
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22792007
Citation
Cusack SL, Jaros M, Kuss M, Minkowitz HS, Winkle P, Hemsen L. Clinical evaluation of XaraColl((R)), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies. J Pain Res. 2012;5:217-25. doi: 10.2147/JPR.S33453. Epub 2012 Jun 27.
Results Reference
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Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy

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