Recruiting

ESPBs vs. TAPs

Sponsor:

University of Kansas Medical Center

Code:

NCT06091241

Conditions

Pain

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Pre-operative Erector Spinae Plane block prior to DIEP surgery

Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery

Study Details

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 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

Conditions

Pain

Study ID

NCT06091241

Start date

Nov 1, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Group 1: Erector Spinae Plane blocks

Erector Spinae Plane blocks

other: Group 2: Transversus Abdominis Plane blocks

Transversus Abdominis Plane blocks

Interventions

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.

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.

Primary outcome measure

  • Numerical Rating Scale [ Time Frame: 24 hours post injection ]
  • Mean Morphine Equivalents [ Time Frame: 24 hours post injection ]

Central Contacts and Locations

Central contacts

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Tara Notarianni, DO

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Jun 4, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-06-04.