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

NCT ID: NCT03152929

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2019-05-21

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paravertebral Block

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

Group Type: ACTIVE_COMPARATOR

Paravertebral Block

Intervention Type: DRUG

20-30 mL 0.5% Ropivacaine

Pectoral Nerve Block

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)

Group Type: ACTIVE_COMPARATOR

Pectoral Nerve Block

Intervention Type: DRUG

20-30 mL 0.5% Ropivacaine

Interventions

Paravertebral Block

20-30 mL 0.5% Ropivacaine

Intervention Type: DRUG

Pectoral Nerve Block

20-30 mL 0.5% Ropivacaine

Intervention Type: DRUG

Other Intervention Names

PVB; PEC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Health Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Melink, MD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Locations

Esther L Peariso

Grand Rapids, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-306

Identifier Type: -

Identifier Source: org_study_id