Breast Cancer Clinical Trial

Paravertebral Block Versus Pectoral Nerve Block

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 and the pectoral nerve block. Postoperative pain control is essential following any major operative procedure. A variety of methods have been utilized to ensure adequate analgesia, 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.

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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.

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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:

Neoadjuvent 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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

128

Study ID:

NCT03152929

Recruitment Status:

Recruiting

Sponsor:

Spectrum Health Hospitals

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There is 1 Location for this study

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Spectrum Health
Grand Rapids Michigan, 49503, United States More Info
Travis Krautwurst, BS
Contact
616-391-2724
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

128

Study ID:

NCT03152929

Recruitment Status:

Recruiting

Sponsor:


Spectrum Health Hospitals

How clear is this clinincal trial information?

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