Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
- Conditions
- MammaplastyPain, Postoperative
- Interventions
- Registration Number
- NCT04278846
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- undergoing breast reconstruction with tissue expander
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DepoFoam bupivacaine Depofoam bupivacaine local anesthetic Bupivacaine hydrochloride (HCl) Bupivacaine hydrochloride (HCl) local anesthetic
- Primary Outcome Measures
Name Time Method 48 Hour Pain Assessment Numeric Rating Scale During Rest 48 hours post-operatively 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 Hour Pain Assessment Numeric Rating Scale During Rest 60 hours post-operatively 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 Hour Pain Assessment Numeric Rating Scale During Rest 72 hours post-operatively 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 10.24 Hour Pain Assessment Numeric Rating Scale During Rest 24 hours post-operatively 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 Hour Pain Assessment Numeric Rating Scale During Rest 36 hours post-operatively 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)1 Hour Pain Assessment Numeric Rating Scale During Rest 1 hour post-operatively 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)
8-12 Hour Pain Assessment Numeric Rating Scale During Rest 8-12 hours post-operatively 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)
84 Hour Pain Assessment Numeric Rating Scale During Rest 84 hours post-operatively 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 10.96 Hour Pain Assessment Numeric Rating Scale During Rest 96 hours post-operatively 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 0-1036 Hour Pain Assessment Numeric Rating Scale During Activity 36 hours post-operatively 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 Hour Pain Assessment Numeric Rating Scale During Activity 48 hours post-operatively 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 Hour Pain Assessment Brief Pain Inventory 72 hours post-operatively 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
60 Hour Pain Assessment Numeric Rating Scale During Activity 60 hours post-operatively 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 Hour Pain Assessment Numeric Rating Scale During Activity 72 hours post-operatively 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 Hour Pain Assessment Numeric Rating Scale During Activity 84 hours post-operatively 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 Hour Pain Assessment Numeric Rating Scale During Activity 96 hours post-operatively 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 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction 96 hours post-operatively 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)
48 Hour Pain Assessment Brief Pain Inventory 48 hours post-operatively 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 Hour Pain Assessment Brief Pain Inventory 24 hours post-operatively 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 Hour Pain Assessment Brief Pain Inventory 96 hours post-operatively 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
- Secondary Outcome Measures
Name Time Method 24 Hour Use of Rescue Analgesic 24 hours post operatively We will record the amount in milligrams and type of rescue analgesic for each patient.
48 Hour Use of Rescue Analgesic 48 hours post operatively We will record the amount in milligrams and type of rescue analgesic for each patient.
72 Hour Use of Rescue Analgesic 72 hours post operatively We will record the amount in milligrams and type of rescue analgesic for each patient.
96 Hour Use of Rescue Analgesic 96 hours post operatively We will record the amount in milligrams and type of rescue analgesic for each patient.
Trial Locations
- Locations (1)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States