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Phase 2B Upper Extremity Nerve Block Study

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ClinicalTrials.gov Identifier: NCT03011333
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Brief Summary:
This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectoral nerve block before surgery.

Condition or disease Intervention/treatment Phase
Analgesia Drug: HTX-011 Drug: Bupivacaine HCl without epinephrine Drug: Saline Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty
Actual Study Start Date : January 14, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : March 19, 2018

Arm Intervention/treatment
Experimental: Group 1
HTX-011 60 mg
Drug: HTX-011
Experimental: Group 2
HTX-011 120 mg
Drug: HTX-011
Experimental: Group 3
HTX-011 240 mg
Drug: HTX-011
Experimental: Group 4
HTX-011 400 mg
Drug: HTX-011
Active Comparator: Group 5
Bupivacaine HCl 50 mg
Drug: Bupivacaine HCl without epinephrine
Placebo Comparator: Group 6
Saline Placebo
Drug: Saline Placebo



Primary Outcome Measures :
  1. Mean area under the curve (AUC) of the NRS-R pain intensity scores [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Mean total postoperative opioid consumption (in morphine equivalents) [ Time Frame: 72 Hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is scheduled to undergo primary bilateral submuscular augmentation mammoplasty with saline or silicone smooth implants with a volume of 300 to 500 cc, inclusive. Note: textured implants are not allowed.
  • Has an American Society of Anesthesiologists Physical Status of I, II, or III.
  • Subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

  • Has a planned concurrent surgical procedure.
  • Has a planned reconstructive procedure status post breast cancer therapy.
  • Has a 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 medication.
  • Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
  • Has taken NSAIDs within 10 days prior to scheduled surgery.
  • Has been administered bupivacaine within 5 days prior to the scheduled surgery.
  • Has been administered any local anesthetic within 72 hours prior to the scheduled surgery other than to treat an AE that occurs after signing the ICF or for pretreatment prior to a needle placement.
  • Has initiated treatment with any of the following medications within 1 month prior to study drug administration or is taking any of these medications to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 (COX-2) inhibitors. (Note: If a subject is taking one of these medications for a reason other than pain control, she must be on a stable scheduled dose [ie, not "as needed"] for at least 1 month prior to study drug administration.) Anxiolytics prior to surgery are permitted, if necessary.
  • Has a medical condition 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, Hepatitis C, or human immunodeficiency virus (HIV).
  • Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
  • Has any chronic neuromuscular deficit of either pectoral nerve function or arm/shoulder/truncal musculature.
  • Has any chronic condition or disease that would compromise neurological or vascular assessments.
  • Had a malignancy in the last year, with the exception of non-metastatic 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 in 12 months.
  • Has a body mass index (BMI) >35 kg/m2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011333


Locations
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United States, California
Pasadena, California, United States, 91105
United States, Texas
Houston, Texas, United States, 77027
Sponsors and Collaborators
Heron Therapeutics

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Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT03011333     History of Changes
Other Study ID Numbers: HTX-011-211
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Epinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents