Trials / Recruiting
RecruitingNCT06091241
ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- Sponsor
- University of Kansas Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2026-07-15
- Completion
- 2026-12-31
- First posted
- 2023-10-19
- Last updated
- 2025-07-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06091241. Inclusion in this directory is not an endorsement.