Liposomal Bupivacaine vs Bupivacaine With Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies

Breast Cancer Clinical Trial

Official title: Liposomal Bupivacaine vs Bupivacaine With Dexmedetomidine in an Erector Spinae Plane Block for Mastectomies in Cancer Patients: A Randomized Control Trial

Status Not yet recruiting

Clinical Trial Summary

Perform a comparison of effective pain relief duration between liposomal bupivacaine and dexmedetomidine when added to bupivacaine in a block for mastectomy for cancer surgery. The erector spinae plane block is a well-established block that is utilized for post operative pain control for procedures performed on the soft tissue of the chest and chest wall as well as intrathoracic procedures. The goal is comparison of the effective duration of both study groups to determine if there is a significant difference in time and amount of post operative opioids required which admitted to hospital.

Clinical Trial Description

Performance of a single-blinded randomized control trial to evaluate effectiveness of postoperative pain control in erector spinae plane blocks with bupivacaine with liposomal bupivacaine as the control versus bupivacaine with dexmedetomidine. Plan to randomize patients by alternating months, so that odd months' patients will receive bupivacaine 0.25% with liposomal bupivacaine in the erector spinae plane block. Even months patients will receive bupivacaine 0.25% with dexmedetomidine in the erector spinae plane block. Block will be performed with ultrasound by the APS team. A time out confirming location of surgery, allergies, consents completed prior to start of the block. Patients will be monitored with 5 lead electrocardiography, non-invasive blood pressure, and pulse oximetry. After skin wheal with 1% lidocaine via 25-27 g needle and echogenic 20 g needle will be utilized to perform the block. The needle will be placed under direct ultrasound visualization into the ESP plane. The plane will be hydro dissected with normal saline to confirm needle tip has accessed the erector spinae plane. The local anesthetic will be given in a total of 0.2 ml/kg up to 20 mls (selected based on the study group placement) and aspiration will occur every 5 mls during the block. This will be repeated on the second side if a bilateral block is indicated in based on the surgical consent. All patients will receive 10 mg IV dexamethasone post-induction of anesthesia. While the patient is in patient pain scores and milligrams of morphine equivalence (MMEs) will be collected every 6 hours based on charting by the nurses providing care starting from time "0" in the PACU after surgery, up until discharge. Then to obtain pain scores up to 72 hours after surgery, patients will be called at home after 72 hours and asked what their pain scores had been daily since discharge and a total of tabs taken daily. ;

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT06252662
• Study type: Interventional
• Source: United States Naval Medical Center, Portsmouth
• Contact: Grant A Miller, DO
• Phone: 757-953-3238
• Email: grant.a.miller7.mil@health.mil
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2024
• Completion date: July 2025