Breast Reconstruction, Postoperative Pain
Conditions
Keywords
TAP block, Regional block, ERAS, liposomal bupivacaine, free flap
Brief summary
Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and transversus abdominis muscle. It is shown to help with post-operative pain management, reducing pain scores and narcotic pain medication use, as well as promoting earlier return to activity and recovery. TAP block became a very popular, safe, and effective therapeutic adjunct for many different abdominal surgeries ranging from obstetric procedures to general surgery procedures like colorectal surgery. Furthermore, it is used in plastic surgery procedures such as Deep Inferior Epigastric Perforator (DIEP) free flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap, as they involve extensive amount of abdominal soft tissue incision. Previous studies have shown that TAP block in these procedures significantly reduce post-op pain and narcotic pain medication use. More recently, Exparel (liposomal bupivacaine) has risen to spotlight for providing a longer, sustained local anesthesia. Various surgical disciplines have adopted this agent as part of their pain management protocol. However, there are no literatures that describe the effect of TAP block using Exparel for breast free flap population. The study hypothesize that delivering TAP block with Exparel (vs. plain bupivacaine) will provide longer regional blocking effect, hence aiding in pain control and recovery postoperatively. The investigators will be analyzing postop narcotic pain medication requirement and pain scores to look into this question.
Interventions
Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
DRUGBupivacain
Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Control group: TAP block with plain bupivacaine Intervention group: TAP block with plain bupivacaine + liposomal bupivacaine
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center
Exclusion criteria
* Subjects with ages \<18 years * Allergy to local anesthetic * Inability to tolerate standard postoperative pain management regimen (Tylenol, Toradol, and Oxycodone PRN) for any reason * Subjects who cannot read or understand English * Subjects who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-op Narcotic Pain Medication Use During Hospitalization | during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first | total amount of morphine milliequivalent |
| Post-op Pain Scores During Initial Hospitalization | During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first | Visual analog pain scale. Scores range from 0 to 10, 0 being no pain and 10 being worse pain that one experienced in their lifetime. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first | hospital length of stay |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control - Plain Bupivacaine Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively
Bupivacain: Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control. | 59 |
| Experimental - Liposomal Bupivacaine Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively
Liposomal bupivacaine TAP block: Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control. | 58 |
| Total | 117 |
Baseline characteristics
| Characteristic | Control - Plain Bupivacaine | Experimental - Liposomal Bupivacaine | Total |
|---|---|---|---|
| Age, Continuous | 51.9 Years STANDARD_DEVIATION 10.5 | 51.1 Years STANDARD_DEVIATION 8.7 | 51.6 Years STANDARD_DEVIATION 9.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 59 Participants | 58 Participants | 117 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 / 59 | 0 / 58 |
| other Total, other adverse events | 0 / 59 | 0 / 58 |
| serious Total, serious adverse events | 0 / 59 | 0 / 58 |
Outcome results
Primary
Post-op Narcotic Pain Medication Use During Hospitalization
total amount of morphine milliequivalent
Time frame: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control - Plain Bupivacaine | Post-op Narcotic Pain Medication Use During Hospitalization | 55 MME |
| Experimental - Liposomal Bupivacaine | Post-op Narcotic Pain Medication Use During Hospitalization | 50 MME |
Primary
Post-op Pain Scores During Initial Hospitalization
Visual analog pain scale. Scores range from 0 to 10, 0 being no pain and 10 being worse pain that one experienced in their lifetime.
Time frame: During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control - Plain Bupivacaine | Post-op Pain Scores During Initial Hospitalization | 4.3 score on a scale |
| Experimental - Liposomal Bupivacaine | Post-op Pain Scores During Initial Hospitalization | 3.3 score on a scale |
Secondary
Length of Hospital Stay
hospital length of stay
Time frame: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Plain Bupivacaine | Length of Hospital Stay | 2.1 Days | Standard Deviation 0.4 |
| Experimental - Liposomal Bupivacaine | Length of Hospital Stay | 2.2 Days | Standard Deviation 0.6 |