ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

Study Overview
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Brief Summary
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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

Official Title
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ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

Conditions
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Pain

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1: Erector Spinae Plane blocks<br>Erector Spinae Plane blocks | Procedure: Pre-operative Erector Spinae Plane block prior to DIEP surgery<br>* 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% bupivacaine with dexamethasone will be injected below the fascia of the erector spinae muscle group.<br>* Other names: ESPBs;|
| Other: Group 2: Transversus Abdominis Plane blocks<br>Transversus Abdominis Plane blocks | Procedure: Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery<br>* 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% bupivacaine with dexamethasone will be injected into the transversus abdominus plane above the transversus abdominus muscle.<br>* Other names: TAPs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale | Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable') | 24 hours post injection | 
| Mean Morphine Equivalents | Amount of opioid pain medications administered and converted to morphine equivalents | 24 hours post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale | Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable') | 12 hours post injection | 
| Michigan Body Map | Map used to show body location of worst site of primary pain | 24 hours post injection | 
| Mean Morphine Equivalents | Amount of opioid pain medications administered and converted to morphine equivalents | 48 hours post injection | 
| Numerical Rating Scale | Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable') | 48 hours post injection | 
| Numerical Rating Scale | Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable') | 3 months post-operation | 
| Numerical Rating Scale | Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable') | 6 months post-operation |