AnalgesiaPhase 4NCT04102267
Extended Delivery of Bupivacaine Study in Herniorrhaphy
A Phase 4 study testing Bupivacaine liposome injectable suspension and Bupivacaine HCl without epinephrine via continuous infusion in people with Analgesia, run by Heron Therapeutics at 1 site in United States.
Trial summary
This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- Bupivacaine liposome injectable suspension and Bupivacaine HCl without epinephrine via continuous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 26 Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia
- Has an American Society of Anesthesiologists Physical Status of I, II, or III
- Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile,or using acceptable contraceptives.
Who cannot join
- Had any prior inguinal hernia repair
- Has a planned concurrent surgical procedure
- Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications
- Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
- Has taken any NSAIDs within least 10 days prior to the scheduled surgery
Show all 18Show fewer
- Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting)
- Has been administered bupivacaine within 5 days prior to the scheduled surgery.
- Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
- Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug
- Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments
- Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C
- Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments
- Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
- Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.
- Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives
- Has undergone 3 or more surgeries within 12 months
- Has a body mass index (BMI) >39 kg/m2.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
About this study
Official title: A Randomized, Phase 4 Study of the Efficacy, Safety, and Pharmacokinetics of Bupivacaine Administered as Liposomal Bupivacaine or Continuous Infusion Via Elastomeric Pump Following Unilateral Open Inguinal Herniorrhaphy
This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.
- Conditions
- Analgesia
- Being tested
- Bupivacaine liposome injectable suspension, Bupivacaine HCl without epinephrine via continuous infusion
- Keywords
- herniorrhaphy, inguinal hernia, hernia, hernia surgery, postoperative pain
- Medical subject headings
- Agnosia, Hernia, Inguinal, Hernia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine liposome injectable suspensionDrug
Liposomal bupivacaine 266 mg via injection
Bupivacaine HCl without epinephrine via continuous infusionDrug
Bupivacaine HCl 300 mg via continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine injection (Group 1) | Experimental | Liposomal bupivacaine 266 mg via injection Receives: Drug: Bupivacaine liposome injectable suspension |
| Bupivacaine HCl continuous infusion (Group 2) | Experimental | Bupivacaine HCl 300 mg via continuous infusion Receives: Drug: Bupivacaine HCl without epinephrine via continuous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72)
Measured: 72 hours
Secondary outcomes (4)
Total postoperative opioid consumption (in morphine equivalents)
Measured: 72 hours
Proportion of subjects who are opioid-free
Measured: 72 hours
Median time in hours to first opioid rescue medication
Measured: 72 hours
Mean AUC0-72 of the NRS-R pain intensity scores.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start2 Jul 2018
- Primary completion3 Sep 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heron Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102267
- Sponsor's protocol ID
- BUPI-501
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 4 Study of the Efficacy, Safety, and Pharmacokinetics of Bupivacaine Administered as Liposomal Bupivacaine or Continuous Infusion Via Elastomeric Pump Following Unilateral Open Inguinal Herniorrhaphy
- ClinicalTrials.gov ID
- NCT04102267
- Acronym / sponsor ID
- BUPI-501
- Conditions
- Analgesia
- Keywords
- herniorrhaphy, inguinal hernia, hernia, hernia surgery, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine injection (Group 1) | Experimental | Drug: Bupivacaine liposome injectable suspensionLiposomal bupivacaine 266 mg via injection |
| Bupivacaine HCl continuous infusion (Group 2) | Experimental | Drug: Bupivacaine HCl without epinephrine via continuous infusionBupivacaine HCl 300 mg via continuous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia
- Has an American Society of Anesthesiologists Physical Status of I, II, or III
- Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile,or using acceptable contraceptives.
Key exclusion criteria (18 listed)
- Had any prior inguinal hernia repair
- Has a planned concurrent surgical procedure
- Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain
- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications
- Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine liposome injectable suspensionLiposomal bupivacaine 266 mg via injection | Drug | Liposomal bupivacaine injection (Group 1) |
| Bupivacaine HCl without epinephrine via continuous infusionBupivacaine HCl 300 mg via continuous infusion | Drug | Bupivacaine HCl continuous infusion (Group 2) |
Primary outcome
Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72)
Time frame: 72 hours
4 secondary outcomes
Total postoperative opioid consumption (in morphine equivalents)
Time frame: 72 hours
Proportion of subjects who are opioid-free
Time frame: 72 hours
Median time in hours to first opioid rescue medication
Time frame: 72 hours
Mean AUC0-72 of the NRS-R pain intensity scores.
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine liposome injectable suspension and Bupivacaine HCl without epinephrine via continuous infusion in people with Analgesia, run by Heron Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.