Comparing pain relief methods for mastectomy patients
Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in an Erector Spinae Plane Block for Mastectomies in Cancer Patients: a Randomized Control Trial
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | United States Naval Medical Center, Portsmouth Federal |
| Locations | 1 site (Portsmouth, Virginia) |
| Trial ID | NCT06252662 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients requiring mastectomy with or without axillary lymph node dissection who agree to a peripheral nerve block.
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.
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 performed: Previous studies have shown promising results with similar approaches in pain management, suggesting potential for success in this trial.
Eligibility criteria
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 this trial is running
Portsmouth, Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.