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

Paravertebral Block Versus Pectoral Nerve Block for Analgesia Following Mastectomy

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Paravertebral Block; Drug: Pectoral Nerve Block

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Esther L Peariso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paravertebral Block; The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)	Drug: Paravertebral Block; 20-30 mL 0.5% Ropivacaine; Other Names: PVB
Active Comparator: 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)	Drug: Pectoral Nerve Block; 20-30 mL 0.5% Ropivacaine; Other Names: PEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Narcotic Use	Participants for whom Narcotics were used for pain during surgery	intraoperatively, average of about 1 hour
Post Anesthesia Care Unit (PACU) Narcotic Use	Participants for whom Narcotics were used in PACU	in PACU, generally 1-3 hours
Postoperative Narcotic Use	Participants for whom Narcotics were used postoperatively	First 24 hours post-PACU (or until discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Control Measured by Length of Operation	Measuring pain control by how long (in minutes) patient is in surgery	intraoperative
Pain Control Measured by Estimated Blood Loss	Measuring blood loss (in ml) during surgery	intraoperative
Participants With Postoperative Nausea	count of participants who reported nausea after surgery	2 weeks postoperative
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
Pain Control Measured by the Use of Pain Pills Postoperatively	Participants who used narcotic pain pills postoperatively	2 weeks postoperative
Pain Control Measured by Calls to Physicians Office Relating to Pain	Number of phone calls made to physician office regarding pain	2 weeks postoperative

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals
• Investigators: Principal Investigator: Marianne Melink, MD, Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2017
• Primary Completion (Actual): May 21, 2019
• Study Completion (Actual): May 21, 2019

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Analgesia; Mastectomy; Breast; Pectoral Nerve Block; Paravertebral Block
• Other Study ID Numbers: 2016-306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No