ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

Not Applicable

Not yet recruiting

• Conditions: Pain
• Interventions: Procedure: Pre-operative Erector Spinae Plane block prior to DIEP surgery; Procedure: Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery

• Registration Number: NCT06091241
• Lead Sponsor: University of Kansas Medical Center

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 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-03
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Study First Posted: 2023-10-19
• Last Update Posted: 2023-10-19
• Study Start: 2023-11-01
• Primary Completion: 2026-07-15
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

• Adult women with breast cancer, ASA 1-3, undergoing DIEP flap surgery

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Exclusion Criteria

• Chronic opioid use contraindications to local anesthetics or regional analgesia Inability to communicate intensity of pain on a numeric analog scale

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale	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')
Mean Morphine Equivalents	24 hours post injection	Amount of opioid pain medications administered and converted to morphine equivalents

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States