ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

Pain Clinical Trial

Official title:

ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06091241
• Other study ID #: STUDY00150240
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: University of Kansas Medical Center
• Contact: Rachel Henning
• Phone: 9139458072
• Email: rhenning2[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: December 31, 2026
• Est. primary completion date: July 15, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mean Morphine Equivalents	Amount of opioid pain medications administered and converted to morphine equivalents	24 hours post injection
Secondary	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
Secondary	Michigan Body Map	Map used to show body location of worst site of primary pain	24 hours post injection
Secondary	Mean Morphine Equivalents	Amount of opioid pain medications administered and converted to morphine equivalents	48 hours post injection
Secondary	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
Secondary	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
Secondary	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