NCT04278846

Brief Summary

Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken. This information will be used to determine if liposomal bupivacaine provides better and longer pain control vs. bupivacaine HCl.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 1, 2022

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

3.4 years

First QC Date

December 28, 2016

Results QC Date

November 4, 2021

Last Update Submit

June 7, 2022

Conditions

Pain, PostoperativeMammaplasty

Outcome Measures

Primary Outcomes (20)

  • 1 Hour Pain Assessment Numeric Rating Scale During Rest

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) Scale name: Numeric rating scale during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

    1 hour post-operatively

  • 8-12 Hour Pain Assessment Numeric Rating Scale During Rest

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

    8-12 hours post-operatively

  • 24 Hour Pain Assessment Numeric Rating Scale During Rest

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

    24 hours post-operatively

  • 36 Hour Pain Assessment Numeric Rating Scale During Rest

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

    36 hours post-operatively

  • 48 Hour Pain Assessment Numeric Rating Scale During Rest

    Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

    48 hours post-operatively

  • 60 Hour Pain Assessment Numeric Rating Scale During Rest

    Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

    60 hours post-operatively

  • 72 Hour Pain Assessment Numeric Rating Scale During Rest

    Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

    72 hours post-operatively

  • 84 Hour Pain Assessment Numeric Rating Scale During Rest

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

    84 hours post-operatively

  • 96 Hour Pain Assessment Numeric Rating Scale During Rest

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R). The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) Range 0-10

    96 hours post-operatively

  • 36 Hour Pain Assessment Numeric Rating Scale During Activity

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

    36 hours post-operatively

  • 48 Hour Pain Assessment Numeric Rating Scale During Activity

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain,0 meaning no pain) The range is 0 to 10.

    48 hours post-operatively

  • 60 Hour Pain Assessment Numeric Rating Scale During Activity

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

    60 hours post-operatively

  • 72 Hour Pain Assessment Numeric Rating Scale During Activity

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

    72 hours post-operatively

  • 84 Hour Pain Assessment Numeric Rating Scale During Activity

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

    84 hours post-operatively

  • 96 Hour Pain Assessment Numeric Rating Scale During Activity

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A). The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

    96 hours post-operatively

  • 24 Hour Pain Assessment Brief Pain Inventory

    Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

    24 hours post-operatively

  • 48 Hour Pain Assessment Brief Pain Inventory

    Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

    48 hours post-operatively

  • 72 Hour Pain Assessment Brief Pain Inventory

    Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

    72 hours post-operatively

  • 96 Hour Pain Assessment Brief Pain Inventory

    Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

    96 hours post-operatively

  • 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction

    Pain will be assessed qualitatively through the use of post-operative analgesia patient satisfaction scale (0-5) The higher scores indicate more satisfied patients.( 5 would be very satisfied-less pain, 0 would indicate unsatisfied patients-more pain)

    96 hours post-operatively

Secondary Outcomes (4)

  • 24 Hour Use of Rescue Analgesic

    24 hours post operatively

  • 48 Hour Use of Rescue Analgesic

    48 hours post operatively

  • 72 Hour Use of Rescue Analgesic

    72 hours post operatively

  • 96 Hour Use of Rescue Analgesic

    96 hours post operatively

Study Arms (2)

DepoFoam bupivacaine

EXPERIMENTAL

local anesthetic

Drug: Depofoam bupivacaine

Bupivacaine hydrochloride (HCl)

ACTIVE COMPARATOR

local anesthetic

Drug: Bupivacaine hydrochloride (HCl)

Interventions

Depofoam bupivacaineDRUG

The study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Also known as: liposomal bupivacaine, Exparel
DepoFoam bupivacaine
Bupivacaine hydrochloride (HCl)DRUG

The study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Also known as: Marcaine
Bupivacaine hydrochloride (HCl)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll eligible patients, 18 and over, undergo breast reconstruction with tissue expanders.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing breast reconstruction with tissue expander

You may not qualify if:

  • history of adverse reaction to local anesthesia
  • chronic liver disease
  • history of chronic preoperative consumption of narcotics or opioids
  • history of alcohol and/or illicit drug dependence
  • undergoing combined procedures
  • diagnosed with neuromuscular/neurosensory disorder
  • positive pregnancy test
  • previous breast conservation therapy (lumpectomy with radiation treatment
  • previous surgeries or trauma in the breast or chest region (denervation may bias pain perception)
  • axillary node dissection
  • psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Raymond Isakov, MD
Organization
Cleveland Clinic
ISAKOVR@ccf.org
216 445-3765

Study Officials

  • Raymond Isakov, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2016

First Posted

February 20, 2020

Study Start

August 22, 2014

Primary Completion

December 31, 2017

Study Completion

May 15, 2019

Last Updated

July 1, 2022

Results First Posted

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)