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CompletedNCT04102267Updated Sep 26, 2019

Extended Delivery of Bupivacaine Study in Herniorrhaphy

A Phase 4 interventional study of Bupivacaine liposome injectable suspension and Bupivacaine HCl without epinephrine via continuous infusion in Analgesia, sponsored by Heron Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Heron Therapeutics · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Sep 2018, 8 years 1 month ago, and no results have been posted to the registry.
  • Registered 1 year 2 months after the study started (first participant enrolled Jul 2018, registered Sep 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Analgesia

Keywords

  • herniorrhaphy
  • inguinal hernia
  • hernia
  • hernia surgery
  • postoperative pain
03

In context

Lead sponsor

Heron Therapeutics is the lead sponsor of 25 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Liposomal bupivacaine injection (Group 1)

    Liposomal bupivacaine 266 mg via injection

    Drug: Bupivacaine liposome injectable suspension

  • Experimental
    Bupivacaine HCl continuous infusion (Group 2)

    Bupivacaine HCl 300 mg via continuous infusion

    Drug: Bupivacaine HCl without epinephrine via continuous infusion

Interventions

  • DrugBupivacaine liposome injectable suspension

    Liposomal bupivacaine 266 mg via injection

  • DrugBupivacaine HCl without epinephrine via continuous infusion

    Bupivacaine HCl 300 mg via continuous infusion

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Total postoperative opioid consumption (in morphine equivalents)

    Time frame: 72 hours

  2. Proportion of subjects who are opioid-free

    Time frame: 72 hours

  3. Median time in hours to first opioid rescue medication

    Time frame: 72 hours

  4. Mean AUC0-72 of the NRS-R pain intensity scores.

    Time frame: 72 hours

07

Study locations

1 site
  • Anaheim Clinical Trials, LLC
    Anaheim, California 92801, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04102267
Lead sponsor
Heron Therapeutics
Responsible party
Sponsor
First posted
Sep 25, 2019
Start date
Jul 2, 2018
Primary completion
Sep 3, 2018
Completion
Oct 26, 2018
Last update
Sep 26, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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