ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Procedure: Pre-operative Erector Spinae Plane block prior to DIEP surgery; Procedure: Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Clark; Phone Number: 9139455763; Email: mclark16@kumc.edu
• Study Contact Backup: Name: Rachel Keller; Phone Number: 9139458072; Email: rkeller@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Rachel Henning; Phone Number: 9139458072; Email: rhenning2@kumc.edu
      • Principal Investigator: Tara Notarianni, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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% ropivacaine 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% ropivacaine will be injected into the transversus abdominus plane above the transversus abdominus muscle.; Other Names: TAPs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale	Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')	12 hours post injection
Michigan Body Map	Map used to show body location of worst site of primary pain	24 hours post injection
Mean Morphine Equivalents	Amount of opioid pain medications administered and converted to morphine equivalents	48 hours post injection
Numerical Rating Scale	Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')	48 hours post injection
Numerical Rating Scale	Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')	1 week post-operation
Numerical Rating Scale	Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')	2 weeks post-operation
Numerical Rating Scale	Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')	6 weeks post-operation

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac hydroxyethylpyrrolidine
• Other Study ID Numbers: STUDY00150240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No