Comparing pain relief methods for mastectomy patients
Official title: Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in an Erector Spinae Plane Block for Mastectomies in Cancer Patients: a Randomized Control Trial
Run by United States Naval Medical Center, Portsmouth · NCT06252662 · Data updated 2026-11-12
This study is testing whether a new pain relief method using liposomal bupivacaine works better than the standard bupivacaine with dexmedetomidine for patients recovering from mastectomy surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | United States Naval Medical Center, Portsmouth Federal |
| Locations | 1 site (Portsmouth, Virginia) |
| Status | Recruiting |
| Started | October 15, 2024 |
| Main results expected | July 2025 |
| Study ends | October 2025 |
| Registry record updated | November 19, 2024 |
| Trial ID | NCT06252662 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients requiring mastectomy with or without axillary lymph node dissection who agree to a peripheral nerve block.
✕Probably not a fit
Patients who decline a peripheral nerve block or have contraindications such as allergies to local anesthetics or active infections at the block site may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares the effectiveness of liposomal bupivacaine versus bupivacaine with dexmedetomidine in providing postoperative pain relief for patients undergoing mastectomy. It employs a single-blinded randomized control design, where patients are assigned to receive one of the two treatments based on the month of their surgery. The erector spinae plane block will be performed under ultrasound guidance by the Acute Pain Service team, ensuring precise delivery of the anesthetic. The study aims to evaluate the duration of pain relief and the amount of opioids required post-surgery.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for mastectomy patients, potentially reducing opioid consumption.
How similar studies have gone: Previous studies have shown promising results with similar approaches in pain management, suggesting potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients requiring any variation of mastectomy with or without axillary lymph node dissection. * Patient agrees to a peripheral nerve block. * Patient agrees to be a study participant. * APS team believes a peripheral nerve block would be appropriate for the patient after reviewing medical/surgical history. * Surgeon agrees with the block plan by APS. Exclusion Criteria: * Patient declines a peripheral nerve block. * Patient declines to be a study participant. * APS team believes a peripheral nerve block is not clinically indicated. * Surgeon does not want a peripheral nerve block. * Patient has allergy to local anesthestic. * Patient has an active infection at the site of the peripheral nerve block. * Patient with pre-existing neural deficits along the distribution of the block. * Patient with coagulopathy. * Patient taking antithrombotic drugs outside the ASRA guidelines. * Patients weight is less that 50 kg due to concerns for local anesthetic toxicity syndrome.
Where it's running
-
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States Recruiting
Study contacts
- Study coordinator: Grant A Miller, DO
- Email: grant.a.miller7.mil@health.mil
- Phone: 757-953-3238
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.