Pain
Conditions
Brief summary
Breast cancer is the second most common cancer diagnosed in American women . For patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps are the gold standard for autologous breast reconstruction . Effective pain control following surgery is imperative and ultrasound-guided bilateral transversus abdominis plane blocks (TAPs) with the infiltration of local anesthetics, such a ropivacaine are a common regional technique of choice . A newer described technique, bilateral Erector Spinae Plane blocks (ESPBs) (which also are an infiltration of local anesthetic) present as an alternative approach for post-operative analgesia. ESPBs have been proven efficacious in reducing intra- and post-operative opioid requirements, lessening the need for rescue analgesics in other similar surgical procedures. The hypothesis is that preoperative bilateral ESPBs could provide equivalent pain control as a regional analgesic for patients undergoing DIEP flap surgery when compared to preoperative bilateral TAPs
Interventions
PROCEDUREPre-operative Erector Spinae Plane block prior to DIEP surgery
After obtaining informed consent to participate in the study, patients will be randomized by a computer 50/50 to either the Erector Spinae Plane group or the Transversus Abdominus Plane group at the time of their surgical clinic visit prior to their scheduled surgery. Then on the morning of surgery, the Erector Spinae Plane group will receive a bilateral ultrasound-guided Erector Spinae Plane peripheral nerve block. During this intervention, 0.25% ropivacaine will be injected below the fascia of the erector spinae muscle group.
PROCEDUREPre-operative Transversus Abdominus Plane blocks prior to DIEP surgery
On the morning of surgery, the patients in the TAPs group will receive a bilateral ultrasound-guided Transversus Abdominus plane peripheral nerve block. During this intervention, 0.25% ropivacaine will be injected into the transversus abdominus plane above the transversus abdominus muscle.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The principal investigator will be unblinded. The study coordinator will be blinded, unable to access procedure notes and randomization assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult women with breast cancer, ASA 1-3, undergoing DIEP flap surgery
Exclusion criteria
* Chronic opioid use contraindications to local anesthetics or regional analgesia Inability to communicate intensity of pain on a numeric analog scale
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale | 24 hours post injection | Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable') |
| Mean Morphine Equivalents | 24 hours post injection | Amount of opioid pain medications administered and converted to morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale | 12 hours post injection | Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable') |
| Michigan Body Map | 24 hours post injection | Map used to show body location of worst site of primary pain |
| Mean Morphine Equivalents | 48 hours post injection | Amount of opioid pain medications administered and converted to morphine equivalents |
Countries
United States
Contacts
CONTACTRachel Keller
CONTACTManuel Clark
Outcome results
None listed