Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)

Spectrum Health Hospitals

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Pectoral Nerve Block; Drug: Paravertebral Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03152929

2016-306

Details and patient eligibility

About

The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing breast surgery. The two methods being compared are the paravertebral block (PVB) and the pectoral nerve block (PEC). Postoperative pain control is essential following any major operative procedure. A variety of methods have been used to ensure adequate pain control, each with its own advantages and risks. Increasingly, attention has focused on regional methods of analgesia, which may allow for reduction in systemic narcotic use and their associated complications. Proposed benefits of regional analgesia and a resultant reduction in narcotic use include decreased risk of cancer progression, decreased length of stay, and decreased risk of ileus.

Full description

The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques. The most common regional block used to achieve postoperative analgesia following mastectomy is the paravertebral block, during which local anesthetic is injected into the paravertebral space which contains the thoracic spinal nerves, between the costotransverse ligament and the pleura. At our institution there has been recent interest in an alternative regional block. The pectoral nerve block is performed by injecting anesthetic between the pectoralis major and the pectoralis minor (PECs I) or between the pectoralis minor and the serratus anterior (PEC II).

The proposed advantage of the pectoral nerve block for regional anesthesia during breast surgery is equal analgesic efficacy with fewer potential complications.

Enrollment: 89 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients ≥ 18 years of age
• Total mastectomy or partial mastectomy with or without reconstruction OR planned lumpectomy.
• Patient determined by their surgeon as medically able to receive a regional block for post-operative analgesia
• Patient agrees to participate in the study and signs informed consent

Exclusion criteria

• Neoadjuvant radiation therapy
• Stage IV cancer
• Previous breast surgery (excluding percutaneous biopsies of all types)
• History of either PVB or PEC procedures
• Planned general anesthesia use during surgery
• Allergies to ropivacaine, midazolam, fentanyl, or propofol
• Pregnant women
• Prisoners
• Adults unable to consent
• Non-English-speaking patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Paravertebral Block

Active Comparator group

Description:

The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)

Treatment:

Drug: Paravertebral Block

Pectoral Nerve Block

Active Comparator group

Description:

The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)

Treatment:

Drug: Pectoral Nerve Block