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ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

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University of Kansas

Status

Enrolling

Conditions

Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06091241
STUDY00150240

Details and patient eligibility

About

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

Enrollment

102 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

102 participants in 2 patient groups

Group 1: Erector Spinae Plane blocks
Other group
Description:
Erector Spinae Plane blocks
Treatment:
Procedure: Pre-operative Erector Spinae Plane block prior to DIEP surgery
Group 2: Transversus Abdominis Plane blocks
Other group
Description:
Transversus Abdominis Plane blocks
Treatment:
Procedure: Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery

Trial contacts and locations

1

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Central trial contact

Manuel Clark; Rachel Henning

Data sourced from clinicaltrials.gov

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