Post-Mastectomy Analgesia Using Exparel (Liposomal) Versus Standard Bupivacaine or Placebo

NCT03504865 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 2018-0175
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, single-blinded placebo-controlled trial. Patients will be randomized to one of three arms: (1) injection of liposomal bupivacaine at the end of the operation, (2) injection of standard bupivacaine at the end of the operation, or (3) no injection of local anesthetic. All patients will be able to receive IV and oral narcotic medications in the postoperative period on an as-needed basis. If a patient is randomized to the LB arm, at the appropriate time, under a surgeon's direction, 266 mg of (liposomal bupivacaine) LB in 20 cc of solution was expanded with various amounts of normal saline to cover the appropriate surgical field. Our routine expansion for a bilateral mastectomy is to add 80 mL of saline to 20 mL (266 mg) of LB. In our practice,we use an 18-gauge needle to inject the medication in a "field-effect" encompassing all 4 quadrants of the chest muscles (pectoralis and serratus) followed by injecting around the edges of the skin incision and drain site. This occurs prior to dissection of the pectoralis muscle and implant or tissue expander placement. Patients randomized to the SB arm will receive weight-based dosing of bupivacaine, administered in the same manner as the LB arm. Patients who are in the placebo arm will have a similar volume of saline injected into the operative site. Postoperatively, all patients will be kept in the hospital for at least one night. Total length of stay will be documented. They will all have the option of receiving IV morphine injections as well as oral acetaminophen-hydrocodone as needed for additional pain control. The administration of these additional medications will be recorded for each patient. On postoperative day 1, each patient will be administered the American Pain Society Outcome Questionnaire while in the hospital. After discharge from the hospital, we will call the patient on postoperative day 2, 3, 5 and 7 to assess pain and satisfaction scores, using the same questions each time. For any patients staying in the hospital longer than 1 day, the questionnaire will be administered in the hospital on the same postoperative days. Subject participation only lasts for these 7 days of follow up.

Conditions

Mastectomy; Breast Cancer

Keywords

Exparel; Bupivacaine

Outcome Measures

Primary Outcomes (2)

• Postop pain and satisfaction scores

  Using a validated questionnaire - the American Pain Society Outcome Questionnaire

  1 week

• The Number of adverse events

  As measured by number by the CTCAE v4.03

  1 week

Secondary Outcomes (3)

• Overall narcotic use

  1 week

• Time in recovery

  1 week

• Time from recovery to discharge

  1 week

Study Arms (3)

Liposomal bupivacaine

EXPERIMENTAL

If a patient is randomized to the LB arm, at the appropriate time, under a surgeon's direction, 266 mg of (liposomal bupivacaine) LB in 20 cc of solution was expanded with various amounts of normal saline to cover the appropriate surgical field. Our routine expansion for a bilateral mastectomy is to add 80 mL of saline to 20 mL (266 mg) of LB. In our practice,we use an 18-gauge needle to inject the medication in a "field-effect" encompassing all 4 quadrants of the chest muscles (pectoralis and serratus) followed by injecting around the edges of the skin incision and drain site. This occurs prior to dissection of the pectoralis muscle and implant or tissue expander placement.

Drug: Liposomal bupivacaine

Standard bupivacaine

ACTIVE COMPARATOR

Patients randomized to the SB arm will receive weight-based dosing of bupivacaine, administered in the same manner as the LB arm.

Drug: Standard bupivacaine

Placebo

PLACEBO COMPARATOR

Patients who are in the placebo arm will have a similar volume of saline injected into the operative site.

Other: Placebo

Interventions

Liposomal bupivacaine DRUG

Given at the end of the operation.

Also known as: Exparel

Liposomal bupivacaine

Standard bupivacaine DRUG

Given at the end of the operation.

Standard bupivacaine

Placebo OTHER

Saline will be administered as the placebo and will be given at the end of the operation.

Placebo

Eligibility Criteria

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

You may qualify if:

• All female patients over 18
• Subjects must be scheduled to undergo bilateral therapeutic or prophylactic skin or nipple-sparing mastectomy at Medstar Georgetown University Hospital
• Subjects must have immediate reconstruction consisting of either tissue expander placement or direct implant placement at the time of mastectomy
• subjects are capable of giving informed consent

You may not qualify if:

• Subjects cannot be homeless persons
• Subjects cannot have active drug/alcohol dependence or abuse history.
• Subjects cannot be pregnant
• Subjects cannot have documented chronic or recent opioid use as well as chronic pain syndromes
• We will exclude any patients who will plan to undergo postoperative whole breast radiation
• Subjects cannot have bupivacaine (and all related analog) allergies

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Eleni Tousimis, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni Tousimis, MD

CONTACT

202-444-8595; eleni.a.tousimis@gunet.georgetown.edu

Study Design

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

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: July 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)