Clinical trial NCT04278846: Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
Official title: Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Mammaplasty
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2020-02-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 1 Hour Pain Assessment Numeric Rating Scale During Rest
timeFrame: 1 hour post-operatively
measure: 8-12 Hour Pain Assessment Numeric Rating Scale During Rest
timeFrame: 8-12 hours post-operatively
measure: 24 Hour Pain Assessment Numeric Rating Scale During Rest
timeFrame: 24 hours post-operatively
measure: 36 Hour Pain Assessment Numeric Rating Scale During Rest
timeFrame: 36 hours post-operatively
measure: 48 Hour Pain Assessment Numeric Rating Scale During Rest
timeFrame: 48 hours post-operatively
measure: 60 Hour Pain Assessment Numeric Rating Scale During Rest
timeFrame: 60 hours post-operatively
measure: 72 Hour Pain Assessment Numeric Rating Scale During Rest
timeFrame: 72 hours post-operatively
measure: 84 Hour Pain Assessment Numeric Rating Scale During Rest
timeFrame: 84 hours post-operatively
measure: 96 Hour Pain Assessment Numeric Rating Scale During Rest
timeFrame: 96 hours post-operatively
measure: 36 Hour Pain Assessment Numeric Rating Scale During Activity
timeFrame: 36 hours post-operatively
measure: 48 Hour Pain Assessment Numeric Rating Scale During Activity
timeFrame: 48 hours post-operatively
measure: 60 Hour Pain Assessment Numeric Rating Scale During Activity
timeFrame: 60 hours post-operatively
measure: 72 Hour Pain Assessment Numeric Rating Scale During Activity
timeFrame: 72 hours post-operatively
measure: 84 Hour Pain Assessment Numeric Rating Scale During Activity
timeFrame: 84 hours post-operatively
measure: 96 Hour Pain Assessment Numeric Rating Scale During Activity
timeFrame: 96 hours post-operatively
measure: 24 Hour Pain Assessment Brief Pain Inventory
timeFrame: 24 hours post-operatively
measure: 48 Hour Pain Assessment Brief Pain Inventory
timeFrame: 48 hours post-operatively
measure: 72 Hour Pain Assessment Brief Pain Inventory
timeFrame: 72 hours post-operatively
measure: 96 Hour Pain Assessment Brief Pain Inventory
timeFrame: 96 hours post-operatively
measure: 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction
timeFrame: 96 hours post-operatively
Secondary outcomes:
measure: 24 Hour Use of Rescue Analgesic
timeFrame: 24 hours post operatively
measure: 48 Hour Use of Rescue Analgesic
timeFrame: 48 hours post operatively
measure: 72 Hour Use of Rescue Analgesic
timeFrame: 72 hours post operatively
measure: 96 Hour Use of Rescue Analgesic
timeFrame: 96 hours post operatively
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Raymond Isakov, MD
role: PRINCIPAL_INVESTIGATOR
References: