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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278846
• Other study ID #: 14-903
• Status: Completed
• Phase: Phase 4
• Start date: August 22, 2014
• Est. completion date: May 15, 2019

Study information

• Verified date: June 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 15, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mammaplasty
• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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