ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06091241
Status
Recruiting
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Conditions

  • Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Pre-operative Erector Spinae Plane block prior to DIEP surgery — PROCEDURE
    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.
  • Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery — PROCEDURE
    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.

Study Details

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

Key Dates

Start date
Nov 1, 2023
Status verified
May 2026
Primary completion
Jul 15, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Other: Group 1: Erector Spinae Plane blocks
    Erector Spinae Plane blocks
  • Other: Group 2: Transversus Abdominis Plane blocks
    Transversus Abdominis Plane blocks

Primary Outcome Measure

Numerical Rating Scale [ Time Frame: 24 hours post injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Rachel Henning
[email protected]
9139458072
Tara Notarianni, DO (PRINCIPAL_INVESTIGATOR)

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By research site
University of Kansas Medical Center· Kansas City, KS

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