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

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ClinicalTrials.gov Identifier: NCT02601027
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast - Female Procedure: TAP block Device: Nimbus Infusion Pump IV Administration Drug: bupivacaine infusion Drug: acetominophen Drug: Hydromorphone Drug: Oxycodone Drug: Ondansetron Phase 3

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : November 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Placebo Comparator: Placebo
sham TAP catheter with saline infusion
Procedure: TAP block
Device: Nimbus Infusion Pump IV Administration
Drug: acetominophen
Drug: Hydromorphone
Drug: Oxycodone
Drug: Ondansetron
Experimental: TAP catheter
infusion of 0.125% bupivacaine through TAP catheter
Procedure: TAP block
Device: Nimbus Infusion Pump IV Administration
Drug: bupivacaine infusion
Drug: acetominophen
Drug: Hydromorphone
Drug: Oxycodone
Drug: Ondansetron



Primary Outcome Measures :
  1. Post-operative Narcotic Usage [ Time Frame: 48 hours ]
    Total oral morphine equivalents of narcotic used in first 48 hours post-operatively after breast reconstruction. Post-operative Narcotic Usage will be measured in total oral morphine equivalents (OME) calculated by summing all narcotics used in the first 48 hours post-operatively.


Secondary Outcome Measures :
  1. Post-operative Pain Score [ Time Frame: 48 hours ]
    Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient reported pain score on a scale of 0-10.

  2. Post-operative Anti-emetic Usage [ Time Frame: 48 hours ]
    Post-operative Anti-emetic Usage is defined as the total amount of IV ondansetron administered to a patient during the first 48 hours post-operatively.

  3. Time to Ambulation [ Time Frame: up to 1 week ]
    Time to Ambulation is defined as the time to the first instance a patient is able to stand up and walk a few steps post-operatively. The time of first ambulation will be recorded by the nurse on shift. Time to Ambulation will be calculated from midnight on POD 1.

  4. Time to First Bowel Movement [ Time Frame: up to 1 week ]
    Time to First Bowel Movement is defined as the time to the first instance a patient passes stool post-operatively. The time of first bowel movement will be recorded by the nurse on shift. Time to First Bowel Movement will be calculated from midnight on POD 1.

  5. Quality of Life Measurement [ Time Frame: 6 months ]
    Quality of Life is defined as the calculated score from the BREAST-Q questionnaire. Quality of Life will be measured by having the patient fill out the BREAST-Q questionnaire preoperatively, as well as post-operatively between 1-6 months after surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601027


Locations
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United States, California
Stanford Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Afaaf Shakir       ashakir@stanford.edu   
Principal Investigator: Gordon K. Lee, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Gordon K. Lee, MD Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02601027     History of Changes
Other Study ID Numbers: BRS0058
34315
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Bupivacaine
Oxycodone
Ondansetron
Hydromorphone
Acetaminophen
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents
Analgesics, Non-Narcotic
Antipyretics