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Purpose

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 bupivacaine 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

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
Female
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)
Masking Description
The principal investigator will be unblinded. The study coordinator will be blinded, unable to access procedure notes and randomization assignment

Arm Groups

ArmDescriptionAssigned Intervention
Other
Group 1: Erector Spinae Plane blocks 		Erector Spinae Plane blocks
  • Procedure: Pre-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% bupivacaine with dexamethasone will be injected below the fascia of the erector spinae muscle group.
    Other names:
    • ESPBs
Other
Group 2: Transversus Abdominis Plane blocks 		Transversus Abdominis Plane blocks
  • Procedure: Pre-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% bupivacaine with dexamethasone will be injected into the transversus abdominus plane above the transversus abdominus muscle.
    Other names:
    • TAPs

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Rachel Henning
9139458072
rhenning2@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Rachel Henning
9139458072
rhenning2@kumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.