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Recruiting NCT06091241

ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

No phase Interventional Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pre-operative Erector Spinae Plane block prior to DIEP surgery, Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

  • 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
  • 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.

Primary outcome measures

  • Numerical Rating Scale [Time frame: 24 hours post injection]
  • Mean Morphine Equivalents [Time frame: 24 hours post injection]
Secondary outcome measures (7)
  • Numerical Rating Scale [Time frame: 12 hours post injection]
  • Michigan Body Map [Time frame: 24 hours post injection]
  • Mean Morphine Equivalents [Time frame: 48 hours post injection]
  • Numerical Rating Scale [Time frame: 48 hours post injection]
  • Numerical Rating Scale [Time frame: 1 week post-operation]
  • Numerical Rating Scale [Time frame: 2 weeks post-operation]
  • Numerical Rating Scale [Time frame: 6 weeks post-operation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Kansas Medical Center — Kansas City

Identifiers

NCT: NCT06091241 · STUDY00150240

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗