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

Breast Cancer Clinical Trial

Official title:

Paravertebral Block Versus Pectoral Nerve Block for Analgesia Following Mastectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03152929
• Other study ID #: 2016-306
• Status: Terminated
• Phase: Phase 3
• Start date: March 9, 2017
• Est. completion date: May 21, 2019

Study information

• Verified date: June 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: May 21, 2019
• Est. primary completion date: May 21, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Paravertebral Block
20-30 mL 0.5% Ropivacaine
• Pectoral Nerve Block
20-30 mL 0.5% Ropivacaine

Locations

Country	Name	City	State
United States	Esther L Peariso	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Narcotic Use	Participants for whom Narcotics were used for pain during surgery	intraoperatively, average of about 1 hour
Primary	Post Anesthesia Care Unit (PACU) Narcotic Use	Participants for whom Narcotics were used in PACU	in PACU, generally 1-3 hours
Primary	Postoperative Narcotic Use	Participants for whom Narcotics were used postoperatively	First 24 hours post-PACU (or until discharge)
Secondary	Pain Control Measured by Length of Operation	Measuring pain control by how long (in minutes) patient is in surgery	intraoperative
Secondary	Pain Control Measured by Estimated Blood Loss	Measuring blood loss (in ml) during surgery	intraoperative
Secondary	Participants With Postoperative Nausea	count of participants who reported nausea after surgery	2 weeks postoperative
Secondary	Pain Control Measured by Pain Scale	Pain measured on scale of one to ten, one being least amount of pain and ten the greatest.	2 weeks postoperative
Secondary	Pain Control Measured by the Use of Pain Pills Postoperatively	Participants who used narcotic pain pills postoperatively	2 weeks postoperative
Secondary	Pain Control Measured by Calls to Physicians Office Relating to Pain	Number of phone calls made to physician office regarding pain	2 weeks postoperative