Pain, Postoperative
Conditions
Brief summary
This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate reconstruction.
Detailed description
This research hopes to determine the duration of patient-reported analgesia provided by ultrasound guided PEC II field block injections. The design of the study randomly assigns the side of injection of the study drugs into each patient. All patients are having bilateral mastectomy with immediate reconstruction. Visual analog pain scores (VAS) will be recorded serially for both sides of the patient's chest in hopes of determining a difference in duration and efficacy of the two drugs. In addition to VAS scores, a subjective, binary question will be our primary outcome: does one side of your chest have more surgical pain than the other? We hope that his question, despite being entirely subjective, overcomes interpatient variability of numerical pain score reporting.
Interventions
DRUGLiposomal bupivacaine right injection
Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
DRUGLiposomal bupivacaine left injection
Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
Sponsors
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Only anesthesiologist performing injection will be aware of which side is injected with each drug.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Scheduled for bilateral mastectomy
Exclusion criteria
* allergy to local anesthetics, prior breast surgery, asymmetric surgical plan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Bilateral Pain Comparison | up to 48 hours | Subjective, binary question Does one side of your chest have more surgical pain than the other? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Analgesia | up to 48 hours | Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine Left Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right
Liposomal bupivacaine left injection: Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. | 4 |
| Liposomal Bupivacaine Right Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left
Liposomal bupivacaine right injection: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. | 1 |
| Total | 5 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine Left | Liposomal Bupivacaine Right | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Continuous | 59.25 years | 44 years | 56.2 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment United States | 4 participants | 1 participants | 5 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 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 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Subjective Bilateral Pain Comparison
Subjective, binary question Does one side of your chest have more surgical pain than the other?
Time frame: up to 48 hours
Population: Patients undergoing bilateral mastectomy with immediate reconstruction by breast surgeons at Greenville Health System.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine Left | Subjective Bilateral Pain Comparison | 1 Participants |
| Liposomal Bupivacaine Right | Subjective Bilateral Pain Comparison | 0 Participants |
Secondary
Duration of Analgesia
Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale
Time frame: up to 48 hours
Population: Patients undergoing bilateral mastectomy with immediate reconstruction by breast surgeons at Greenville Health System.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Liposomal Bupivacaine Left | Duration of Analgesia | 21.5 hours |
| Liposomal Bupivacaine Right | Duration of Analgesia | 36 hours |