Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/13/2019 |
| Start Date: | November 2015 |
| End Date: | December 2019 |
A Phase III Study of Pre-operative Transversus Abdominis Plane Blocks Using the Nimbus Ambulatory Infusion System in Patients Undergoing Abdominal Free Flap-based Breast Reconstruction
The purpose of this trial is to determine if using abdominal nerve blocks when patient
undergo breast reconstruction can significantly decrease use of pain medications after
reconstructive surgery.
undergo breast reconstruction can significantly decrease use of pain medications after
reconstructive surgery.
Primary Objective: The primary objective is to determine if pre-operative transversus
abdominis plane (TAP) blocks with continued infusion of local anesthetic post-operatively
affect post-operative narcotic usage as compared to a placebo TAP block.
Secondary Objective:
- To determine if pre-operative TAP blocks with continued infusion of local anesthetic
post-operatively affect post-operative pain scores as compared to a placebo TAP block.
- To determine if pre-operative TAP blocks with continued infusion of local anesthetic
post-operatively affect anti-emetic usage as compared to a placebo TAP block.
- To determine if pre-operative TAP blocks with continued infusion of local anesthetic
post-operatively affect time to ambulation post-operatively as compared to a placebo TAP
block.
- To determine if pre-operative TAP blocks with continued infusion of local anesthetic
post-operatively affect time to first bowel movement as compared to a placebo TAP block.
- To determine if pre-operative TAP blocks with continued infusion of local anesthetic
post-operatively affect patient-reported quality of life as compared to a placebo TAP
block.
abdominis plane (TAP) blocks with continued infusion of local anesthetic post-operatively
affect post-operative narcotic usage as compared to a placebo TAP block.
Secondary Objective:
- To determine if pre-operative TAP blocks with continued infusion of local anesthetic
post-operatively affect post-operative pain scores as compared to a placebo TAP block.
- To determine if pre-operative TAP blocks with continued infusion of local anesthetic
post-operatively affect anti-emetic usage as compared to a placebo TAP block.
- To determine if pre-operative TAP blocks with continued infusion of local anesthetic
post-operatively affect time to ambulation post-operatively as compared to a placebo TAP
block.
- To determine if pre-operative TAP blocks with continued infusion of local anesthetic
post-operatively affect time to first bowel movement as compared to a placebo TAP block.
- To determine if pre-operative TAP blocks with continued infusion of local anesthetic
post-operatively affect patient-reported quality of life as compared to a placebo TAP
block.
Inclusion Criteria
- Prior diagnosis or presumed diagnosis of breast cancer or undergoing prophylactic
treatment.
- Greater than 18 years old.
- Female.
- Undergoing microsurgical breast reconstruction with abdominal free flap.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- True allergy to local anesthetics or opioids.
- History of addiction to narcotics within the last 24 months
- History of chronic pain on opioids within the last 24 months.
- Specific mental health issues such as schizophrenia or bipolar disorder.
- Patients who are pregnant.
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