Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Mammaplasty
• Intervention / Treatment: Drug: Depofoam bupivacaine; Drug: Bupivacaine hydrochloride (HCl)

Detailed Description

Fifty consecutive (25 per arm) patients undergoing unilateral or bilateral breast reconstruction with tissue expanders will be administered intraoperatively in a standardized manner with either bupivicaine HCl (control group) or liposomal bupivacaine/Exparel (experimental group). Pain will be assessed qualitatively through the use of: 1) numeric rating scale during rest (NRS-R) and activity (NRS-A), 2) brief pain inventory (BPI) questionnaire, and 3) postoperative analgesia patient satisfaction scale. Furthermore, investigators will record the use of rescue analgesics for each patient. This part of the study will provide quantitative data that investigators can then use in comparison to the qualitative measurements (NSR, BPI, patient satisfaction scale rate). In turn, this will allow us to objectify patient's pain, thereby increasing the validity of our results. More importantly, this aspect of the investigation will enable us to study the impact that liposomal bupivacaine has in reducing the postoperative usage of opioid medications in this patient population. As this is a pilot study, a sample size of 50 total patients (25 per treatment group) is planned. This sample size should provide estimates of potential effect sizes and variability in the present setting to allow for future study planning. This study should provide adequate evidence of whether pain decreases of 15% or more are unlikely in this setting.

Investigators aim to evaluate the effectiveness of DepoFoam Bupivicaine (Exparel®) to reduce postoperative pain in breast reconstruction patients compared to the current standard treatment (bupivacaine HCl). Investigators hypothesize that patients undergoing breast reconstruction with tissue expander will achieve greater control of post-operative pain and longer lasting analgesia with the use of liposomal bupivacaine.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• undergoing breast reconstruction with tissue expander

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DepoFoam bupivacaine; local anesthetic	Drug: Depofoam bupivacaine; 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.; Other Names: liposomal bupivacaine, Exparel
Active Comparator: Bupivacaine hydrochloride (HCl); local anesthetic	Drug: Bupivacaine hydrochloride (HCl); 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.; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 Hour Use of Rescue Analgesic	We will record the amount in milligrams and type of rescue analgesic for each patient.	24 hours post operatively
48 Hour Use of Rescue Analgesic	We will record the amount in milligrams and type of rescue analgesic for each patient.	48 hours post operatively
72 Hour Use of Rescue Analgesic	We will record the amount in milligrams and type of rescue analgesic for each patient.	72 hours post operatively
96 Hour Use of Rescue Analgesic	We will record the amount in milligrams and type of rescue analgesic for each patient.	96 hours post operatively

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Pacira Pharmaceuticals, Inc
• Investigators: Principal Investigator: Raymond Isakov, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2014
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 14-903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No