ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

NCT06091241 | Recruiting

• 1 other identifier: STUDY00150240
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• Numerical Rating Scale

  Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')

  24 hours post injection

• Mean Morphine Equivalents

  Amount of opioid pain medications administered and converted to morphine equivalents

  24 hours post injection

Secondary Outcomes (6)

• Numerical Rating Scale

  12 hours post injection

• Michigan Body Map

  24 hours post injection

• Mean Morphine Equivalents

  48 hours post injection

• Numerical Rating Scale

  48 hours post injection

• Numerical Rating Scale

  3 months post-operation

Study Arms (2)

Group 1: Erector Spinae Plane blocks

OTHER

Erector Spinae Plane blocks

Procedure: Pre-operative Erector Spinae Plane block prior to DIEP surgery

Group 2: Transversus Abdominis Plane blocks

OTHER

Transversus Abdominis Plane blocks

Procedure: Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery

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

Also known as: ESPBs

Group 1: Erector Spinae Plane blocks

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

Also known as: TAPs

Group 2: Transversus Abdominis Plane blocks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women with breast cancer, ASA 1-3, undergoing DIEP flap surgery

You may not qualify if:

• Chronic opioid use contraindications to local anesthetics or regional analgesia Inability to communicate intensity of pain on a numeric analog scale

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rachel Henning

CONTACT

9139458072; rhenning2@kumc.edu

Manuel Clark

CONTACT

9139455763; mclark16@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The principal investigator will be unblinded. The study coordinator will be blinded, unable to access procedure notes and randomization assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: October 19, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)