Bupivacaine HCl collagen-matrix implant for Postoperative Pain

Driscoll Children's Hospital, Corpus Christi, TX
Postoperative Pain+1 More ConditionsBupivacaine HCl collagen-matrix implant - Drug
2 - 16
All Sexes

Study Summary

This trial is looking at what is the best dose of a new pain medicine for children who are getting surgery to fix an inguinal hernia.

Eligible Conditions
  • Postoperative Pain
  • Inguinal Hernia

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

12 Primary · 6 Secondary · Reporting Duration: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0

Hour 48
Hour 48
1 day at screening
12-lead ECG
Clinical laboratory testing
Hour 48
Pain intensity
30 days
Adverse events
Day 7
Injury wounds
Hour 48
Heart rate
Respiratory rate
Hour 48
Blood pressure (systolic/diastolic)
Hour 3
3-lead ECG
Oxygen saturation levels
Through Day 30
Body temperature

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Active Control

Experimental Treatment

159 Total Participants · 2 Treatment Groups

Primary Treatment: Bupivacaine HCl collagen-matrix implant · No Placebo Group · Phase 3

Experimental Group · 1 Intervention: Bupivacaine HCl collagen-matrix implant · Intervention Types: Drug
ActiveComparator Group · 1 Intervention: Bupivacaine HCl infiltration · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after time 0

Who is running the clinical trial?

InnocollLead Sponsor
20 Previous Clinical Trials
4,831 Total Patients Enrolled
4 Trials studying Postoperative Pain
167 Patients Enrolled for Postoperative Pain
Premier Research Group plcIndustry Sponsor
58 Previous Clinical Trials
54,078 Total Patients Enrolled
4 Trials studying Postoperative Pain
167 Patients Enrolled for Postoperative Pain
Gwendolyn Niebler, DOStudy DirectorInnocoll

Eligibility Criteria

Age 2 - 16 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to be able to communicate in English or Spanish.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

What primary goals does this research project hope to accomplish?

"According to the study sponsor, Innocoll, the primary outcome measure for this trial will be oxygen saturation levels over a period of three days. Secondary outcomes include Tmax (time to maximum observed plasma concentration), AUC0-∞ (area under the plasma concentration time curve from time zero to extrapolated infinity), and pain intensity as assessed using an 11-point NRS scale (for children 12 to <17 years of age), FACES pain severity scale (children 4 through <12 years of age), or FLACC (children 2 and 3 years of age) immediately before receiving any rescue medication for breakthrough pain." - Anonymous Online Contributor

Unverified Answer

Is this study enrolling new participants at the moment?

"Indeed, the clinical trial is recruiting patients as stated on clinicaltrials.gov. The study was posted June 16th, 2017 and updated July 23rd, 2021. They are looking for 159 individuals to participate at 7 different locations." - Anonymous Online Contributor

Unverified Answer

Are there any other precedents for a Bupivacaine HCl collagen-matrix implant?

"There are 124 clinical trials that have bupivacaine hydrochloride collagen-matrix implants as their focus. Of these, 21 are in the third and final stage. The majority of these studies are based out of Philadelphia, Pennsylvania; however, there are a total of 169 locations running these sorts of trials." - Anonymous Online Contributor

Unverified Answer

Might I be eligible to enroll in this clinical trial?

"This study is looking for 159 people, within the ages of 2 and 16 who currently have postoperative pain. It is required that patients also meet the following criteria: Be willing and able to cooperate with all the requirements of the study., Be willing to sign an assent (if appropriate dependent upon the child's age, understanding, and IRB requirements), before the conduct of any study procedure., Be a male or female 2 to <17 years of age., Be premenarche or have a serum confirmed negative pregnancy test at screening and a negative urine pregnancy test before surgery on day 1, if an adolescent female of childbearing" - Anonymous Online Contributor

Unverified Answer

Does the age limit for this research project preclude elderly participation?

"Children aged 2 to 16 can enroll in this clinical trial. Out of the 54 trials available for minors, this is one option. For patients 65 years and older, there are 363 different trials from which they may choose." - Anonymous Online Contributor

Unverified Answer

For what condition is Bupivacaine HCl collagen-matrix implant commonly prescribed?

"The conditions of permphigus, acute nonspecific tenosynovitis, and general anesthesia can all be remedied by Bupivacaine HCl collagen-matrix implant." - Anonymous Online Contributor

Unverified Answer

How many volunteers are being sought for this clinical trial?

"A total of 159 participants who meet the eligibility requirements are required for this clinical trial. Patients can enroll at sites such as El Paso Children's Hospital in El Paso, Pennsylvania and Children's Hospital of Pittsburgh of UPMC (CHP-UPMC) in Pittsburgh, California." - Anonymous Online Contributor

Unverified Answer

Has the Bupivacaine HCl collagen-matrix implant received FDA approval?

"There is both efficacy and safety data available for Bupivacaine HCl collagen-matrix implant, thus it received a score of 3." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.