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NCT Number: NCT06091241

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

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Rachel Henning

CONTACT

[email protected]

9139458072

Tara Notarianni, DO

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ESPBs

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.

Other names: TAPs

Primary outcomes

  1. Numerical Rating Scale

    Time frame: 24 hours post injection

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

  2. Mean Morphine Equivalents

    Time frame: 24 hours post injection

    Amount of opioid pain medications administered and converted to morphine equivalents

Secondary outcomes

  1. Numerical Rating Scale

    Time frame: 12 hours post injection

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

  2. Michigan Body Map

    Time frame: 24 hours post injection

    Map used to show body location of worst site of primary pain

  3. Mean Morphine Equivalents

    Time frame: 48 hours post injection

    Amount of opioid pain medications administered and converted to morphine equivalents

  4. Numerical Rating Scale

    Time frame: 48 hours post injection

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

  5. Numerical Rating Scale

    Time frame: 1 week post-operation

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

  6. Numerical Rating Scale

    Time frame: 2 weeks post-operation

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

  7. Numerical Rating Scale

    Time frame: 6 weeks post-operation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Clark

CONTACT

[email protected]

9139455763

Rachel Keller

CONTACT

[email protected]

9139458072

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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