Mammaplasty, Pain, Postoperative
Conditions
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.
Interventions
DRUGDepofoam 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.
DRUGBupivacaine 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.
Sponsors
Pacira Pharmaceuticals, Inc
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| 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. |
| 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 0-10 |
| 36 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DepoFoam Bupivacaine local anesthetic
Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | 25 |
| Bupivacaine HCl local anesthetic
Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | DepoFoam Bupivacaine | Bupivacaine HCl | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 24 Participants | 48 Participants |
| Region of Enrollment United States | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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)
Time frame: 1 hour post-operatively
Population: All randomized patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 1 Hour Pain Assessment Numeric Rating Scale During Rest | 5 units on a scale |
| Bupivacaine HCl | 1 Hour Pain Assessment Numeric Rating Scale During Rest | 5 units on a scale |
p-value: 0.87Kruskal-Wallis
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
Time frame: 24 hours post-operatively
Population: All patients who used medication
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DepoFoam Bupivacaine | 24 Hour Pain Assessment Brief Pain Inventory | 4 units on a scale |
| Bupivacaine HCl | 24 Hour Pain Assessment Brief Pain Inventory | 5 units on a scale |
p-value: 0.088Kruskal-Wallis
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)
Time frame: 24 hours post-operatively
Population: All randomized patients who completed the tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 24 Hour Pain Assessment Numeric Rating Scale During Rest | 3 units on a scale |
| Bupivacaine HCl | 24 Hour Pain Assessment Numeric Rating Scale During Rest | 3.5 units on a scale |
p-value: 0.57Kruskal-Wallis
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.
Time frame: 36 hours post-operatively
Population: All randomized patients who completed the tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 36 Hour Pain Assessment Numeric Rating Scale During Activity | 5 units on a scale |
| Bupivacaine HCl | 36 Hour Pain Assessment Numeric Rating Scale During Activity | 5 units on a scale |
p-value: 0.94Kruskal-Wallis
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)
Time frame: 36 hours post-operatively
Population: All randomized patients who completed the tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 36 Hour Pain Assessment Numeric Rating Scale During Rest | 3 units on a scale |
| Bupivacaine HCl | 36 Hour Pain Assessment Numeric Rating Scale During Rest | 3 units on a scale |
p-value: 0.3Kruskal-Wallis
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
Time frame: 48 hours post-operatively
Population: All participants who used medication
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DepoFoam Bupivacaine | 48 Hour Pain Assessment Brief Pain Inventory | 3.5 units on a scale |
| Bupivacaine HCl | 48 Hour Pain Assessment Brief Pain Inventory | 4 units on a scale |
p-value: 0.42Kruskal-Wallis
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.
Time frame: 48 hours post-operatively
Population: All randomized patients who completed the tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 48 Hour Pain Assessment Numeric Rating Scale During Activity | 4 units on a scale |
| Bupivacaine HCl | 48 Hour Pain Assessment Numeric Rating Scale During Activity | 5 units on a scale |
p-value: 0.95Kruskal-Wallis
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.
Time frame: 48 hours post-operatively
Population: All patients who completed tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 48 Hour Pain Assessment Numeric Rating Scale During Rest | 3 units on a scale |
| Bupivacaine HCl | 48 Hour Pain Assessment Numeric Rating Scale During Rest | 3 units on a scale |
p-value: 0.99Kruskal-Wallis
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.
Time frame: 60 hours post-operatively
Population: All randomized patients who completed the tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 60 Hour Pain Assessment Numeric Rating Scale During Activity | 5 units on a scale |
| Bupivacaine HCl | 60 Hour Pain Assessment Numeric Rating Scale During Activity | 4 units on a scale |
p-value: 0.54Kruskal-Wallis
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.
Time frame: 60 hours post-operatively
Population: All patients who completed tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 60 Hour Pain Assessment Numeric Rating Scale During Rest | 3 units on a scale |
| Bupivacaine HCl | 60 Hour Pain Assessment Numeric Rating Scale During Rest | 2 units on a scale |
p-value: 0.33Kruskal-Wallis
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
Time frame: 72 hours post-operatively
Population: All participants who used medication
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DepoFoam Bupivacaine | 72 Hour Pain Assessment Brief Pain Inventory | 3 units on a scale |
| Bupivacaine HCl | 72 Hour Pain Assessment Brief Pain Inventory | 3 units on a scale |
p-value: 0.88Kruskal-Wallis
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.
Time frame: 72 hours post-operatively
Population: All randomized patients who completed the tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 72 Hour Pain Assessment Numeric Rating Scale During Activity | 4 units on a scale |
| Bupivacaine HCl | 72 Hour Pain Assessment Numeric Rating Scale During Activity | 4 units on a scale |
p-value: 0.95Kruskal-Wallis
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.
Time frame: 72 hours post-operatively
Population: All randomized patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 72 Hour Pain Assessment Numeric Rating Scale During Rest | 3 units on a scale |
| Bupivacaine HCl | 72 Hour Pain Assessment Numeric Rating Scale During Rest | 2 units on a scale |
p-value: 0.26Kruskal-Wallis
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)
Time frame: 8-12 hours post-operatively
Population: All randomized patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 8-12 Hour Pain Assessment Numeric Rating Scale During Rest | 3 units on a scale |
| Bupivacaine HCl | 8-12 Hour Pain Assessment Numeric Rating Scale During Rest | 3 units on a scale |
p-value: 0.49Kruskal-Wallis
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.
Time frame: 84 hours post-operatively
Population: All randomized patients who completed the tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 84 Hour Pain Assessment Numeric Rating Scale During Activity | 4 units on a scale |
| Bupivacaine HCl | 84 Hour Pain Assessment Numeric Rating Scale During Activity | 3 units on a scale |
p-value: 0.96Kruskal-Wallis
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.
Time frame: 84 hours post-operatively
Population: All randomized patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 84 Hour Pain Assessment Numeric Rating Scale During Rest | 1 units on a scale |
| Bupivacaine HCl | 84 Hour Pain Assessment Numeric Rating Scale During Rest | 2 units on a scale |
p-value: 0.79Kruskal-Wallis
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
Time frame: 96 hours post-operatively
Population: All participants who used medication
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DepoFoam Bupivacaine | 96 Hour Pain Assessment Brief Pain Inventory | 3 units on a scale |
| Bupivacaine HCl | 96 Hour Pain Assessment Brief Pain Inventory | 2 units on a scale |
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.
Time frame: 96 hours post-operatively
Population: All randomized patients who completed the tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 96 Hour Pain Assessment Numeric Rating Scale During Activity | 3.5 units on a scale |
| Bupivacaine HCl | 96 Hour Pain Assessment Numeric Rating Scale During Activity | 3 units on a scale |
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
Time frame: 96 hours post-operatively
Population: All randomized patients who completed the tools
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DepoFoam Bupivacaine | 96 Hour Pain Assessment Numeric Rating Scale During Rest | 1.5 units on a scale |
| Bupivacaine HCl | 96 Hour Pain Assessment Numeric Rating Scale During Rest | 2 units on a scale |
p-value: 0.62Kruskal-Wallis
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)
Time frame: 96 hours post-operatively
Population: All patients using tools
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DepoFoam Bupivacaine | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | 2 | 0 Participants |
| DepoFoam Bupivacaine | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | 4 | 9 Participants |
| DepoFoam Bupivacaine | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | 3 | 0 Participants |
| DepoFoam Bupivacaine | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | 5 | 11 Participants |
| DepoFoam Bupivacaine | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | 1 | 0 Participants |
| Bupivacaine HCl | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | 5 | 8 Participants |
| Bupivacaine HCl | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | 1 | 1 Participants |
| Bupivacaine HCl | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | 2 | 0 Participants |
| Bupivacaine HCl | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | 3 | 2 Participants |
| Bupivacaine HCl | 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction | 4 | 11 Participants |
p-value: 0.12Kruskal-Wallis
Secondary
24 Hour Use of Rescue Analgesic
We will record the amount in milligrams and type of rescue analgesic for each patient.
Time frame: 24 hours post operatively
Population: All patients reporting medication use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DepoFoam Bupivacaine | 24 Hour Use of Rescue Analgesic | 63.3 milligrams | Standard Deviation 29.3 |
| Bupivacaine HCl | 24 Hour Use of Rescue Analgesic | 63.9 milligrams | Standard Deviation 47.8 |
p-value: 0.96t-test, 2 sided
Secondary
48 Hour Use of Rescue Analgesic
We will record the amount in milligrams and type of rescue analgesic for each patient.
Time frame: 48 hours post operatively
Population: All patients reporting medication use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DepoFoam Bupivacaine | 48 Hour Use of Rescue Analgesic | 25.1 milligrams | Standard Deviation 21.5 |
| Bupivacaine HCl | 48 Hour Use of Rescue Analgesic | 23.3 milligrams | Standard Deviation 18.4 |
p-value: 0.76t-test, 2 sided
Secondary
72 Hour Use of Rescue Analgesic
We will record the amount in milligrams and type of rescue analgesic for each patient.
Time frame: 72 hours post operatively
Population: All patients reporting medication use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DepoFoam Bupivacaine | 72 Hour Use of Rescue Analgesic | 20.7 milligrams | Standard Deviation 22.1 |
| Bupivacaine HCl | 72 Hour Use of Rescue Analgesic | 19.9 milligrams | Standard Deviation 15.6 |
p-value: 0.88t-test, 2 sided
Secondary
96 Hour Use of Rescue Analgesic
We will record the amount in milligrams and type of rescue analgesic for each patient.
Time frame: 96 hours post operatively
Population: All patients reporting medication use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DepoFoam Bupivacaine | 96 Hour Use of Rescue Analgesic | 10.2 milligrams | Standard Deviation 11.4 |
| Bupivacaine HCl | 96 Hour Use of Rescue Analgesic | 7.5 milligrams | Standard Deviation 9.4 |
p-value: 0.37t-test, 2 sided