Phase 2B Upper Extremity Nerve Block Study

NCT03011333 | Completed Phase 2 Results

• 1 other identifier: HTX-011-211
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 24 Hours Postsurgery (AUC0-24).

  Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-24 is 0-240. The prescribed activity for NRS-A is keeping the elbows at the side and against the body and then raising both hands in front of the abdomen with hands clasped and holding that position for at least 5 seconds.

  24 hours

Secondary Outcomes (1)

• Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)

  72 Hours

Study Arms (7)

Group 1: HTX-011

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block.

Drug: HTX-011

Group 2: HTX-011

EXPERIMENTAL

HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block.

Drug: HTX-011

Group 3: HTX-011

EXPERIMENTAL

HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block.

Drug: HTX-011

Group 4: HTX-011

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block.

Drug: HTX-011

Group 5: HTX-011

EXPERIMENTAL

HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation.

Drug: HTX-011

Group 6: Bupivacaine HCl

ACTIVE COMPARATOR

Bupivacaine HCl without epinephrine, 50 mg via nerve block.

Drug: Bupivacaine HCl without epinephrine

Group 7: Saline Placebo

PLACEBO COMPARATOR

Saline placebo via nerve block.

Drug: Saline Placebo

Interventions

HTX-011 DRUG

HTX-011 (bupivacaine/meloxicam) via nerve block or instillation.

Group 1: HTX-011; Group 2: HTX-011; Group 3: HTX-011; Group 4: HTX-011; Group 5: HTX-011

Saline Placebo DRUG

Saline placebo via nerve block.

Group 7: Saline Placebo

Bupivacaine HCl without epinephrine DRUG

Bupivacaine HCl without epinephrine, 50 mg via nerve block.

Group 6: Bupivacaine HCl

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (2)

Unknown Facility

Pasadena, California, 91105, United States

Location

Unknown Facility

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Tricia Mulford
• Organization: Heron Therapeutics, Inc.

tmulford@herontx.com

760-622-3709

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Study Start: January 14, 2017
• Primary Completion: February 1, 2018
• Study Completion: March 19, 2018
• Last Updated: March 2, 2026
• Results First Posted: October 29, 2021

Record last verified: 2026-02

Locations

US (2)