A Phase 3 interventional study of Bupivacaine HCl collagen-matrix implant and Bupivacaine HCl infiltration in Inguinal Hernia and Postoperative Pain, sponsored by Innocoll. Status unknown at 11 sites in United States. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-07-30.
Sponsored by Innocoll · Phase 3, Interventional, and Treatment
Among 19 studies testing bupivacaine in Hernia, Inguinal — 1 open to participants now, 2 under way, none of them phase 3. Bupivacaine · Hernia, Inguinal.
Among the 19 studies testing bupivacaine in Hernia, Inguinal, this one is the 5th largest by planned enrollment, is one of 4 that started in 2017, is one of 4 in phase 3, and was the 7th registered.
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's planned enrollment of 159 is above the median of 90 across 395 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →1 of the 19 studies testing bupivacaine in Hernia, Inguinal is open now.
Bupivacaine: first FDA approval 1972 (MARCAINE HYDROCHLORIDE PRESERVATIVE FREE), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 56 Hernia, Inguinal studies recruiting now, 30 (54%) set no upper age limit and 17 (30%) stop at 75 or younger; 16 take children under 18; 9 take healthy volunteers.
This study: 2 Years to 16 Years · all sexes · no healthy volunteers.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 4 started in 2017.
Median enrollment 70 across the 19 interventional studies. Of the 12 that completed or were terminated, 6 (50%) have results posted.
7 of 19 have an industry lead sponsor. The 10 most frequent:
Innocoll is the lead sponsor of 21 studies on the registry; none are open to participants now.
Innocoll has 3 studies filed under Hernia, Inguinal — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 19 studies testing bupivacaine in Hernia, Inguinal, from their registry updates:
Nothing recorded among them since 2026-09-25.
A multicenter, single-dose study in children 12 to \<17 years of age, 6 to \<12 years of age, and 2 to \<6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in this study will start with the oldest age group (12 to \<17 years) and will continue in a stepwise fashion until appropriate doses are established for all 3 pediatric age groups (12 to \<17 years, 6 to \<12 years, 2 to \<6 years).
This is a multicenter, single-dose study in children 12 to \<17 years of age, 6 to \<12 years of age, and 2 to \<6 years of age who are scheduled for elective open inguinal hernia repair. Within 21 days of surgery, eligible subjects will be screened and have routine clinical laboratory testing and an electrocardiogram performed. Subjects will then undergo an open inguinal hernia repair under general anesthesia according to the investigator's standard surgical practice on day 1. Enrollment in this study will start with the oldest age group (12 to \<17 years) and will continue in a stepwise fashion until appropriate doses are established for all 3 pediatric age groups. Within each age group, the study will be conducted in 3 parts.
Children in each age group who are randomized to INL-001 will receive approximately less than or equal to 2.5 mg/kg of INL-001. Study drug will be administered prior to wound closure. The INL-001 implant will be cut before placement into the surgical site using sterile technique. Children randomized to 0.25% bupivacaine HCl injection will receive 2.5 mg/kg according to standard practice.
After completion of the surgical procedure, all subjects will remain in the post-anesthesia care unit for at least 3 hours and will be continuously monitored for safety. At the discretion of the investigator, subjects may receive rescue medication (opioid or nonopioid) upon request for the management of breakthrough pain and may receive an antiemetic for the management of nausea or vomiting. After the initial 3-hour period, subjects who are deemed stable may be discharged to the hospital ward. Subjects will remain housed in the hospital ward for at least 48 hours. Blood samples will be collected for pharmacokinetic analysis from a subset of 8 children in each age group after INL-001 is implanted.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bupivacaine HCl collagen-matrix implant
Drug: Bupivacaine HCl collagen-matrix implant
Bupivacaine HCl infiltration
Drug: Bupivacaine HCl infiltration
Placement of the bupivacaine collagen-matrix in the surgical site
Also known as: Xaracoll
Infiltration of the surgical site
Also known as: Marcaine
Adverse events
Possibly related to bupivacaine toxicity
Time frame: 30 days
Blood pressure (systolic/diastolic)
Signs/symptoms of bupivacaine toxicity
Time frame: Starting at Time 0 and continuing for 3 hours and then 5, 8, 12, 24, 36, and 48 hours after Time 0
Heart rate
Signs/symptoms of bupivacaine toxicity
Time frame: Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0
Respiratory rate
Signs/symptoms of bupivacaine toxicity
Time frame: Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0
Body temperature
Signs/symptoms of bupivacaine toxicity
Time frame: Through Day 30
12-lead ECG
Screening only
Time frame: 1 day at screening
3-lead ECG
Signs/symptoms of bupivacaine toxicity
Time frame: Starting at Time 0 and continuing for at least 3 hours
Oxygen saturation levels
Pulse oximetry
Time frame: Starting at Time 0 and continuing for at least 3 hours
Clinical laboratory testing
Collection of blood and urine samples
Time frame: 1 day at screening
Wound healing assessments
Inspection of surgical wound site for signs of wound infection and dehiscence.
Time frame: Assessment on Day 1 through Day 3; follow-up evaluations on Days 7, 15 and 30
Nausea
Measured using a categorical scoring system (none = 0, mild = 1, moderate = 2, and severe = 3). Nausea scores will also be recorded immediately before the use of rescue antiemetics
Time frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
Sedation
Sedation scores: awake and alert = 0, quietly awake = 1, asleep but easily roused = 2, and deep sleep = 3.
Time frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
Cmax
Maximum observed plasma concentration
Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0.
AUC0-last
Area under the plasma concentration time curve from Time zero to last quantifiable plasma concentration
Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
AUC0-∞
Area under the plasma concentration time curve from Time zero to extrapolated through infinity
Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
Tmax
Time to maximum obserbved plasma concentration
Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
t1/2
Apparent first-order terminal elimination half-life
Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
Pain intensity
Assessed using an 11-point NRS (for children 12 to \<17 years of age), a FACES pain severity scale (children 4 through \<12 years of age), or FLACC (children 2 and 3 years of age) immediately before the child receives any parenteral or oral rescue medication for breakthrough pain
Time frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine