Nerve blocks for pain management in breast reconstruction surgery
Regional Nerve Blocks in Alloplastic Breast Reconstructive Surgery: A Pilot, Randomized Controlled Trial
This study is testing if a combination of two nerve blocks can help reduce pain and opioid use for patients having breast reconstruction surgery after a mastectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | University of British Columbia Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT04860843 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of adding a Pecs block to a thoracic paravertebral block for pain management in patients undergoing mastectomy with immediate breast reconstruction. The study aims to compare the outcomes of patients receiving the combined nerve block versus those receiving a sham block in terms of acute and chronic pain, opioid consumption, and overall recovery. The primary goal is to assess whether the combined approach can reduce opioid use and improve patient-reported pain scores and recovery quality. The trial will also evaluate the feasibility of recruitment and the potential efficacy of this pain management strategy.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 19 and older undergoing total mastectomy with immediate breast reconstruction using tissue expanders or implants.
Not a fit: Patients who may not benefit include those with contraindications for regional blocks, pregnant women, and individuals with certain health conditions or high BMI.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and opioid consumption for patients undergoing breast reconstruction.
How similar studies have performed: Other studies have shown promise in using nerve blocks for pain management in surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients must be female, and at least 19 years old. 2. Patients must be ASA grade I or II. 3. Patients must be undergoing total mastectomy with IBR using tissue expander or implant, with or without axillary surgery. Exclusion Criteria: 1. Patients have a known contraindication for a regional block: known coagulation disorder, treatment with anticoagulants, infection at the injection site, known allergy to medication in the study. 2. Patients who are pregnant at the time of surgery. 3. Patients having bilateral mastectomy and immediate alloplastic breast reconstruction (as only one side can be blocked to prevent local anesthesia toxicity). 4. Patients with ASA Class III or IV. 5. Patients with BMI\>35kg/m2. 6. Patients weighing less than 50kg. 7. Patients living/staying outside of 1-hour driving distance from hospital.
Where this trial is running
Vancouver, British Columbia
- Mount St Joseph Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Kathryn Isaac, MD MPH FRCSC — University of British Columbia
- Study coordinator: Kathryn Isaac, MD MPH FRCSC
- Email: kathryn.isaac@ubc.ca
- Phone: 604-827-0438
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.