Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03705065
Other study ID # BUPI-502
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 19, 2018
Est. completion date November 5, 2018

Study information

Verified date December 2018
Source Heron Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation mammoplasty under general anesthesia.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 5, 2018
Est. primary completion date October 8, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Is scheduled to undergo primary bilateral submuscular augmentation mammoplasty with saline or silicone smooth implants with a volume of 300 to 500 mL, inclusive.

- 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:

- Has a planned concurrent surgical procedure (eg, mastopexy).

- Has a planned concurrent 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 that is not strictly related to the augmentation mammoplasty.

- Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.

- 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.

- 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.

- As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).

- Has uncontrolled anxiety, psychiatric, or neurological disorder.

- 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 at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) 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) >35 kg/m2.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine HCl
Bupivacaine HCl without epinephrine 0.25%, 60 mL (30 mL per pectoral pocket)

Locations

Country Name City State
United States Hermann Drive Surgical Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Observed Plasma Concentration (Cmax) Baseline through 72 hours after start of study drug administration
Primary Area Under the Concentration-time Curve From Time 0 to the Last Collection Time After Study Drug Administration (AUC Last) Baseline through 72 hours after start of study drug administration
Primary Area Under the Concentration-time Curve From Time 0 to Infinity After Study Drug Administration (AUC8) Baseline through 72 hours after start of study drug administration
Primary Time to Maximum Plasma Concentration (Tmax) Baseline through 72 hours after start of study drug administration
Primary The Apparent Terminal Elimination Rate Constant (?z) Baseline through 72 hours after start of study drug administration
Primary The Apparent Terminal Elimination Half-life (t1/2el) Baseline through 72 hours after start of study drug administration
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05534230 - Dexmedetomidine for Pain Reduction in CABG N/A
Recruiting NCT06275698 - HONEY for the Treatment of POst-Tonsillectomy Pain N/A
Recruiting NCT04436224 - Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation Phase 4
Not yet recruiting NCT04548323 - Hypoalgesic Effects of Walking and Running Imagined
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT04394481 - Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery Phase 4
Completed NCT04690647 - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement. N/A
Completed NCT05034601 - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure N/A
Completed NCT03740815 - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection N/A
Recruiting NCT05454202 - Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Recruiting NCT04554186 - Serratus Anterior Plane Block Versus Thoracic Paravertebral Block. N/A
Not yet recruiting NCT06393777 - Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion N/A
Suspended NCT04860635 - Safety of F14 Following Total Knee Replacement Phase 2/Phase 3
Not yet recruiting NCT04519463 - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing Early Phase 1
Completed NCT02916342 - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks Phase 4
Not yet recruiting NCT02549118 - Tenoxicam for Intrapartum Analgesia Phase 2
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Not yet recruiting NCT02190760 - Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block. N/A
Completed NCT01789606 - Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet Phase 3
Completed NCT01299584 - ULTIVA Post Marketing Surveillance N/A