A Phase 4 interventional study of Liposomal bupivacaine right injection and Liposomal bupivacaine left injection in Pain, Postoperative, sponsored by Prisma Health-Upstate. Terminated at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by Prisma Health-Upstate · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right
Drug: Liposomal bupivacaine left injection
Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left
Drug: 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.
Also known as: Exparel Right
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.
Also known as: Exparel Left
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
Duration of Analgesia
Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale
Time frame: up to 48 hours
| Milestone | Liposomal Bupivacaine Left | Liposomal Bupivacaine Right |
|---|---|---|
| Started | 4 | 1 |
| Completed | 4 | 1 |
| Not completed | 0 | 0 |
Subjective, binary question "Does one side of your chest have more surgical pain than the other?"
| Participants | Liposomal Bupivacaine Left | Liposomal Bupivacaine Right |
|---|---|---|
| Subjective Bilateral Pain Comparison | 1 | 0 |
Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale
| hours | Liposomal Bupivacaine Left | Liposomal Bupivacaine Right |
|---|---|---|
| Duration of Analgesia | 21.5 (8 to 42) | 36 (36 to 36) |
Collected over 48 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liposomal Bupivacaine | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Bupivacaine Plus Dexamethasone | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
Patients undergoing bilateral mastectomy with immediate reconstruction at Greenville Memorial Hospital or Patewood Memorial Hospital.
| Age, Categorical(Participants) | Liposomal Bupivacaine Left | Liposomal Bupivacaine Right | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 1 | 4 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Liposomal Bupivacaine Left | Liposomal Bupivacaine Right | Total |
|---|---|---|---|
| Mean | 59.25 (48 to 71) | 44 (44 to 44) | 56.2 (44 to 71) |
| Sex: Female, Male(Participants) | Liposomal Bupivacaine Left | Liposomal Bupivacaine Right | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Liposomal Bupivacaine Left | Liposomal Bupivacaine Right | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 1 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Liposomal Bupivacaine Left | Liposomal Bupivacaine Right | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 1 | 5 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Liposomal Bupivacaine Left | Liposomal Bupivacaine Right | Total |
|---|---|---|---|
| United States | 4 | 1 | 5 |
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Prisma Health-Upstate