ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06091241

Collaborator

(none)

102

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain	Procedure: Pre-operative Erector Spinae Plane block prior to DIEP surgery Procedure: Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The principal investigator will be unblinded. The study coordinator will be blinded, unable to access procedure notes and randomization assignment

Primary Purpose:

Prevention

Official Title:

ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jul 15, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Group 1: Erector Spinae Plane blocks Erector Spinae Plane blocks	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% bupivacaine with dexamethasone will be injected below the fascia of the erector spinae muscle group. Other Names: ESPBs
Other: Group 2: Transversus Abdominis Plane blocks Transversus Abdominis Plane blocks	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% bupivacaine with dexamethasone will be injected into the transversus abdominus plane above the transversus abdominus muscle. Other Names: TAPs

Arm

Intervention/Treatment

Other: Group 1: Erector Spinae Plane blocks

Erector Spinae Plane blocks

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% bupivacaine with dexamethasone will be injected below the fascia of the erector spinae muscle group.

Other Names:

ESPBs

Other: Group 2: Transversus Abdominis Plane blocks

Transversus Abdominis Plane blocks

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% bupivacaine with dexamethasone will be injected into the transversus abdominus plane above the transversus abdominus muscle.

Other Names:

TAPs

Outcome Measures

Primary Outcome Measures

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

Numerical Rating Scale [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')
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
Numerical Rating Scale [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')
Numerical Rating Scale [3 months post-operation]
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
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')

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tara Notarianni, DO, Principal Investigator, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT06091241

Other Study ID Numbers:

STUDY00150240

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diclofenac hydroxyethylpyrrolidine

Study Results

No Results Posted as of Oct 19, 2023