Nerve Blocks for Pain in Breast Reconstruction

Overseen By Cathleen Huang, D.O.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Amy Colwell

Must not be taking: Opioids, Antiepileptics, Nerve medications

Disqualifiers: Morbid obesity, Renal insufficiency, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of nerve blocks to manage pain for individuals receiving breast implants after a mastectomy. It compares paravertebral blocks and pectoral blocks to determine which better aids pain relief and recovery. Candidates for immediate implant-based breast reconstruction who can provide consent may be suitable for this study. However, those who have undergone radiation therapy or use specific medications for nerve pain may not qualify. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance pain management options for future patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used nerve medications like gabapentin or carbamazepine in the past 6 months, or if you are currently using chronic opioids.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both paravertebral and pectoral blocks safely manage pain after breast surgery. Studies indicate that paravertebral blocks provide effective pain relief with minimal side effects. One study found that patients reported less pain and required fewer painkillers post-surgery. Another study noted that complications with this technique are rare.

Similarly, pectoral blocks are safe and effective. They have been shown to lower pain levels and reduce the need for strong pain medications after surgery. A review of several studies found that patients experienced less pain for up to 24 hours post-surgery when a pectoral block was used.

Overall, both treatments are well-tolerated and have a strong safety record in breast surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because paravertebral and pectoral nerve blocks offer a targeted approach to managing pain in breast reconstruction surgery. Unlike systemic pain relief methods like opioids, which can have widespread side effects, these nerve blocks work by numbing specific areas, potentially reducing pain right at the source. This could lead to less overall medication use, quicker recovery, and a more comfortable experience for patients. Additionally, nerve blocks are administered preoperatively, aiming to preemptively manage pain rather than just reacting to it after surgery.

What evidence suggests that this trial's treatments could be effective for pain in breast reconstruction?

This trial will compare two pain relief methods for breast reconstruction surgery: paravertebral blocks (PVB) and pectoral blocks (PECS). Research has shown that PVB can significantly decrease long-term pain after surgery and reduce the need for opioid painkillers. Similarly, PECS blocks lower pain shortly after surgery and also reduce opioid use. PECS blocks are as effective as PVB in managing pain and may even help patients leave the hospital sooner. Both methods are safe and enhance patient comfort after surgery. ^{3 5 6 7 8}

Who Is on the Research Team?

Amy Colwell, M.D.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for patients undergoing immediate implant-based breast reconstruction after breast cancer. Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for the surgical procedure and anesthesia involved.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for breast reconstruction with implants for treatment or prevention.

I understand what the study involves and agree to participate.

Exclusion Criteria

Allergy or contraindication to local anesthetics (PVB or PECS blocks)

My BMI is over 40.

Use of implanted pain devices or neuromodulators

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive either a paravertebral or pectoral block before surgery

1 day

1 visit (in-person)

Postoperative Follow-up

Participants are monitored for pain and physical well-being after surgery

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Paravertebral block
• Pectoral block

Trial Overview The study is testing two types of nerve blocks: a single injection paravertebral block versus a pectoral block, to see which one better manages pain and improves physical well-being post-surgery.

How Is the Trial Designed?

Group I: Pectoral Block Experimental Treatment 1 Intervention

Pectoral block at preop

Group II: Paravertebral Block Active Control 1 Intervention

Paravertebral block at preop

Who Is Running the Clinical Trial?

Amy Colwell

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12411074/

Comparison of Pectoral Nerve and Paravertebral Blocks for ... Results. Of the 42 patients, 23 received a PECS block and 19 received PVB. Successful blocks were achieved in 69.6%, 81.8%, and 77.3 ...

2. academic.oup.com academic.oup.com/painmedicine/article/21/12/3539/5941882

A Randomized Controlled Trial | Pain Medicine | Oxford ... Our results confirmed that PVB reduced the occurrence of CPSP at six months by 48%, further demonstrating the efficacy of PVB in preventing pain ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/tbj.13295

Paravertebral blocks in immediate breast reconstruction ... PVB's were associated with reductions in average postoperative pain scores (2.8 vs 3.3, P = 0.002), total opiate consumption (52 units vs 63 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961022002598

Effects of paravertebral blocks versus liposomal ... In breast surgery, paravertebral blocks (PVB) have been shown to be effective for pain control, decrease length of stay of hospitalization (LOS) and prevent ...

5. mdpi.com mdpi.com/2077-0383/14/6/1832

Paravertebral Blocks in Implant-Based Breast ... In this study, we demonstrated paravertebral blocks to be safe adjuncts in breast reconstruction to minimize pain without leading to increased blood loss or ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20947592/

Efficacy and safety of paravertebral blocks in breast surgery Conclusions: There is considerable evidence that PVB in addition to GA or alone provide a better postoperative pain control with little adverse effects compared ...

7. journals.lww.com journals.lww.com/clinicalpain/fulltext/2024/06000/safety_and_complications_of_landmark_based.5.aspx

Safety and Complications of Landmark-based ... Our study suggests that landmark-based paravertebral blocks for breast surgery result in a very low complication rate and are a safe technique for postsurgical ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK80093/

Efficacy and safety of paravertebral blocks in breast surgery Paravertebral blocks (alone or in combination with general anaesthetic) provided better postoperative pain control with few adverse effects compared with other ...