ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

NCT ID: NCT06091241

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The principal investigator will be unblinded. The study coordinator will be blinded, unable to access procedure notes and randomization assignment

Study Groups

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Group 1: Erector Spinae Plane blocks

Erector Spinae Plane blocks

Group Type OTHER

Pre-operative Erector Spinae Plane block prior to DIEP surgery

Intervention Type 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% bupivacaine with dexamethasone will be injected below the fascia of the erector spinae muscle group.

Group 2: Transversus Abdominis Plane blocks

Transversus Abdominis Plane blocks

Group Type OTHER

Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery

Intervention Type 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% bupivacaine with dexamethasone will be injected into the transversus abdominus plane above the transversus abdominus muscle.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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ESPBs TAPs

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tara Notarianni, DO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rachel Henning

Role: CONTACT

9139458072

Manuel Clark

Role: CONTACT

9139455763

Facility Contacts

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Rachel Henning

Role: primary

9139458072

Other Identifiers

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STUDY00150240

Identifier Type: -

Identifier Source: org_study_id

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