Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA

Stanford University

Status and phase: Completed; Phase 3

Conditions: Breast - Female

Treatments: Drug: Hydromorphone; Drug: Bupivacaine infusion; Drug: Acetominophen; Drug: Ondansetron; Device: Nimbus Infusion Pump IV Administration; Procedure: Transversus Abdominis Plane (TAP) block; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT02601027

BRS0058

IRB-34315

Details and patient eligibility

About

The primary objective is to determine if pre-operative transversus abdominis plane (TAP) nerve blocks by continued infusion of local anesthetic post-operatively affects post-operative narcotic usage, as compared to a placebo TAP block, after breast reconstruction surgery.

Full description

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 Objectives:

• 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.
• 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.
• 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.
• 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.
• 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.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

0.125% Bupivacaine

Experimental group

Description:

0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter

Treatment:

Drug: Oxycodone

Device: Nimbus Infusion Pump IV Administration

Drug: Ondansetron

Procedure: Transversus Abdominis Plane (TAP) block

Drug: Acetominophen

Drug: Bupivacaine infusion

Drug: Hydromorphone

Placebo

Placebo Comparator group

Description:

Saline infusion (sham) via transversus abdominis plane (TAP) catheter.

Treatment:

Drug: Oxycodone

Device: Nimbus Infusion Pump IV Administration

Drug: Ondansetron

Procedure: Transversus Abdominis Plane (TAP) block

Drug: Acetominophen

Drug: Hydromorphone