Extended Delivery of Bupivacaine Study in Herniorrhaphy

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Bupivacaine liposome injectable suspension; Drug: Bupivacaine HCl without epinephrine via continuous infusion

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal bupivacaine injection (Group 1); Liposomal bupivacaine 266 mg via injection	Drug: Bupivacaine liposome injectable suspension; Liposomal bupivacaine 266 mg via injection
Experimental: Bupivacaine HCl continuous infusion (Group 2); Bupivacaine HCl 300 mg via continuous infusion	Drug: Bupivacaine HCl without epinephrine via continuous infusion; Bupivacaine HCl 300 mg via continuous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72)	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who are opioid-free	72 hours
Total postoperative opioid consumption (in morphine equivalents)	72 hours
Median time in hours to first opioid rescue medication	72 hours
Mean AUC0-72 of the NRS-R pain intensity scores.	72 hours

Collaborators and Investigators

• Sponsor: Heron Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): September 3, 2018
• Study Completion (Actual): October 26, 2018

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: hernia; postoperative pain; inguinal hernia; herniorrhaphy; hernia surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: BUPI-501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No