Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

NCT03393117 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CASE10117
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction.

Conditions

Breast Cancer

Keywords

Reconstruction; Bupivacaine; Liposomal Bupivacaine

Outcome Measures

Primary Outcomes (1)

• total post-operative narcotic utilization

  post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine.

  Up to 72 hours post-operative

Secondary Outcomes (7)

• at rest pain score on visual analog scale

  Up to 72 hours post-operative

• coughing pain score on visual analog scale

  Up to 72 hours post-operative

• number of incidents of nausea reported by patient

  Up to 72 hours post-operative

• number of incidents of vomiting reported by patient

  Up to 72 hours post-operative

• time to first ambulation

  Up to 72 hours post-operative

Study Arms (2)

Liposomal Bupivacaine + Bupivacaine

EXPERIMENTAL

This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.

Drug: Liposomal Bupivacaine; Drug: Bupivacaine; Drug: Patient-Controlled Analgesia Pump; Drug: Oral Narcotic

Bupivacaine

ACTIVE COMPARATOR

This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.

Drug: Bupivacaine; Drug: Patient-Controlled Analgesia Pump; Drug: Oral Narcotic

Interventions

Liposomal Bupivacaine DRUG

20mL vial of Liposomal Bupivacaine (266 mg). The infiltration technique for Liposomal Bupivacaine will be 80mL injected into either hemi-abdomen as a transversus abdominous plane (TAP) block via ultrasound guidance. The other 80mL will be utilized in the operative breast for the field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks.

Also known as: Exparel

Liposomal Bupivacaine + Bupivacaine

Bupivacaine DRUG

20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.

Also known as: Sensorcaine-Methyl Paraben Free (MPF) Spinal, Sensorcaine-MPF, Sensorcaine, ReadySharp Bupivacaine, P-Care M, Marcaine Spinal, Marcaine Preservative Free, Marcaine, Bupivacaine Spinal

Bupivacaine; Liposomal Bupivacaine + Bupivacaine

Patient-Controlled Analgesia Pump DRUG

The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.

Also known as: intravenous narcotic

Bupivacaine; Liposomal Bupivacaine + Bupivacaine

Oral Narcotic DRUG

Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.

Bupivacaine; Liposomal Bupivacaine + Bupivacaine

Eligibility Criteria

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

You may qualify if:

• Patients scheduled to have a unilateral, immediate breast reconstruction

You may not qualify if:

• Pregnant
• Concurrent or recent medical condition that could interfere with study participation including:
• Hepatitis
• Alcohol/substance abuse
• Uncontrolled psychiatric disorders
• Known allergy
• Contraindication to amide-type local anesthetics, opioids, or propofol.
• Body weight of less than 50 kg
• Participated in another study involving an investigational medication within the prior 30 days
• Taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bupivacaine; Narcotics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Risal Djohan, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Medication utilized will be blinded in the chart per inpatient pharmacy.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 8, 2018
• Study Start: March 30, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07