What is the mechanism of action of this treatment?

Regional anesthesia, such as the TPVB (Thoracic Paravertebral Block) combined with Pecs (Pectoral Nerve Block), works by blocking nerve signals in specific areas of the body to provide targeted pain relief. This is achieved through the injection of local anesthetics near the nerves, which inhibits the transmission of pain signals to the brain. For plastic surgery patients, this approach is crucial as it can significantly reduce postoperative pain, minimize the need for opioids, and enhance recovery by allowing for better pain management and fewer side effects. Effective pain control is essential for improving patient comfort, reducing hospital stays, and facilitating quicker return to normal activities.

What side effects are associated with this type of intervention?

Common side effects of regional anesthesia techniques like TPVB and Pecs blocks used in plastic surgery include temporary pain at the injection site, bruising, and infection. Patients may also experience transient numbness or weakness in the affected area. In rare cases, there can be complications such as nerve damage, bleeding, or allergic reactions to the anesthetic. Additionally, systemic toxicity from the local anesthetic, though uncommon, can occur, leading to symptoms like dizziness, tinnitus, or seizures.

What prior FDA approvals exist?

The FDA has approved various treatments for pain management in plastic surgery, particularly focusing on regional anesthesia techniques. One such treatment is the use of local anesthetic blocks, like the Transversus Abdominis Plane (TAP) block, which is similar to the TPVB+Pecs block being studied for its efficacy in reducing acute and chronic pain post-surgery. Additionally, the FDA has approved the use of liposomal bupivacaine (Exparel) for prolonged pain relief in surgical sites, which can be used in various types of surgeries, including plastic and reconstructive procedures. These treatments aim to improve pain control, reduce opioid consumption, and enhance patient recovery.

What other types of research exist?

Promising novel alternatives to TPVB+Pecs local anesthetic block for pain control in plastic surgery patients include continuous femoral nerve blocks, adductor canal blocks, and the use of liposomal bupivacaine for prolonged analgesia. These methods have shown efficacy in reducing postoperative pain, minimizing opioid use, and improving patient recovery outcomes.

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Nerve Blocks for Breast Reconstruction

N/A

Recruiting

Led By Kathryn Isaac, MD MPH FRCSC

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be female, and at least 19 years old.

Patients must be ASA grade I or II.

Must not have

Patients weighing less than 50kg.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Summary

This trial is testing if adding an extra pain relief method (Pecs block) to the usual method (TPVB block) helps reduce pain better for patients undergoing mastectomy with immediate breast reconstruction. The treatment works by numbing specific areas to block pain signals. Pectoralis nerve (Pecs) blocks have been shown to reduce the need for opioids during surgery in patients undergoing mastectomies.

Who is the study for?

This trial is for women over 19 years old undergoing mastectomy with immediate breast reconstruction using tissue expanders or implants. They should be in good health (ASA grade I or II) and not too far from the hospital. It's not for those under 50kg, BMI over 35, pregnant, having bilateral reconstructions at once, on anticoagulants, with bleeding disorders, infections at injection sites, allergies to study meds or poor overall health (ASA III/IV).

What is being tested?

The trial tests pain management techniques in breast surgery recovery. It compares a Thoracic paravertebral block (TPVB) combined with Pecs II local anesthetic block against TPVB with a sham Pecs II saline block. The focus is on acute and chronic pain levels, opioid use and side effects, patient recovery quality reports and hospital stay duration.

What are the potential side effects?

Potential side effects may include discomfort at the injection site of the nerve blocks used for anesthesia during surgery which could lead to infection if proper care isn't taken post-operation. Opioid-related side effects might occur due to medication consumption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman and I am 19 years old or older.

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I am in good or mild systemic disease condition.

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I am having a full breast removal with immediate reconstruction using an implant or tissue expander.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh less than 50kg.

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I cannot have a regional block due to a bleeding disorder, medication I'm on, infection, or allergy to the study drug.

Select...

I am having both breasts removed and reconstructed with implants at the same time.

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I have a serious health condition but am not at immediate risk of death.

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My BMI is over 35.

Select...

I live more than an hour's drive from the hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average pain score in the 24-hour post-operative period assessed by the Numerical Rating Scale.

Rate of participant recruitment

Rate of participant retention

+1 more

Secondary study objectives

Acute patient-reported pain scores assessed by the Numerical Rating Scale

Length of stay in hospital in hours

Number of participants requiring rescue opioid analgesics and anti-emetics.

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Local anesthetic TPVB + Local anesthetic Pecs blockExperimental Treatment2 Interventions

Patients will receive a thoracic paravertebral with pecs block, both with local anesthetic infiltrate.

Group II: Local anesthetic TPVB + Sham Pecs blockPlacebo Group2 Interventions

Patients will receive a thoracic paravertebral with local anesthetic infiltrate and a pecs block with saline infiltrate.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pecs block

2020

N/A

~160

Thoracic paravertebral block

2020

Completed Phase 3

~1010

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Regional anesthesia, such as the TPVB (Thoracic Paravertebral Block) combined with Pecs (Pectoral Nerve Block), works by blocking nerve signals in specific areas of the body to provide targeted pain relief. This is achieved through the injection of local anesthetics near the nerves, which inhibits the transmission of pain signals to the brain. For plastic surgery patients, this approach is crucial as it can significantly reduce postoperative pain, minimize the need for opioids, and enhance recovery by allowing for better pain management and fewer side effects. Effective pain control is essential for improving patient comfort, reducing hospital stays, and facilitating quicker return to normal activities.

Local anesthetics and regional anesthesia versus conventional analgesia for preventing persistent postoperative pain in adults and children: A Cochrane systematic review and meta-analysis update.Post-mastectomy cancer recurrence with and without a continuous paravertebral block in the immediate postoperative period: a prospective multi-year follow-up pilot study of a randomized, triple-masked, placebo-controlled investigation.