Paravertebral Versus Pectoralis Block for Post Mastectomy Pain

A Comparison of the Paravertebral Block Versus Pectoralis Block in Controlling Bilateral Post-mastectomy Pain in Setting of Tissue Expander Placement

Post-mastectomy pain affects more than half of patients undergoing the procedure and can last for years. It has been well established that development of chronic pain is related to experienced pain in the perioperative period. This study therefore aims to assess if both acute and chronic post-operative mastectomy pain can be better managed by a novel regional anesthesia nerve block known as the pectoralis block (PECs). The PECs block is easier for patients to position for placement, has less risk of harm to nearby structures, and less risk for systemic uptake of local anesthetic in comparison to the paravertebral block. The PECs block has a strong safety profile. Standard of care at University of Wisconsin (UW) hospital is to utilize regional anesthesia for post op pain management. While PVB is performed on a regular basis at UW per surgeon request, Surgeon can request for PECS block in patients where a PVB was contraindicated (ie. coagulation issues). PECS is in fact the standard of care at other hospitals. This study will assess outcomes in the post anesthetic care unit (PACU), post-operative day 1, 7 and 30.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative; Opioid Use; Post-Mastectomy Chronic Pain Syndrome
• Intervention / Treatment: Procedure: Pectoralis Blockade (PECs); Procedure: Paravertebral Blockade

Detailed Description

Post-mastectomy pain occurs in up to 55% of patients and can last for months. The development of chronic pain is related to experienced perioperative pain. The development of chronic pain is related to experienced perioperative pain. There is great potential to enhance the quality of life for breast surgery patients if the hospital can improve our perioperative pain prevention techniques. New to the spectrum of multimodal analgesia is the pectoralis block (PECs), which provides anesthesia to the anterior and anterior lateral chest wall as well to the axilla. This study is about aims to compare the pectoralis block to paravertebral block with benefits of ease placement, less risk for harm to nearby structures including pneumothorax, spinal cord trauma, sympathetic block and hypotension.

Literature reveals that the pectoralis block has provided improved pain scores as well as decreases post-operative nausea and vomiting, longer block duration, and subsequent pain relief in patient. Despite these promising preliminary studies, there remains a paucity on the effectiveness of the PECs Block, particularly regarding long term outcomes for patients.

Furthermore, there is no literature to date which has evaluated the best regional anesthetic technique for patients who receive breast tissue expanders, which can cause a significant amount of muscle pain and spasm due to the intended muscle disruption during surgical placement. The primary outcomes of this study is to compare total opioid consumption during the post-surgical period limited to 24 hrs beginning at PACU admission between patients who receive bilateral pectoralis plane versus bilateral paravertebral blocks and subsequently undergo bilateral mastectomy with tissue expanders.

The secondary outcomes includes post-operative pain scores on PACU arrival and discharge, post-operative days (POD) 1, 7, and 30, presence/absence of axillary pain, muscle relaxant consumption, presence of severity of muscle spasm, total antiemetic consumption 24-hrs beginning at PACU admission, presence of chronic opioid use (Defined as consumption at 30 days), time to perform block, and PACU duration.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• The clinical decision has been made that the patient will have a bilateral mastectomy with tissue expander placement
• The participant is ≥ 18 years and ≤ 80 years
• Weight ≥ 60 kg and ≤ 90 kg
• The participant's primary anesthesia care team has planned for general anesthesia
• The participant agrees to receive a regional block
• American Society of Anesthesiologists class 1-3

Exclusion Criteria:

• 18 years of age or >80 years of age
• < 60 kg or > 90 kg
• Non-English speaking
• Known or believed to be pregnant
• Participant is a prisoner
• Participant has impaired decision-making capacity per discretion of the Investigator
• Standard contraindications to regional blocks (coagulopathy including abnormal INR after discontinuation of warfarin, baseline INR (international normalized ratio) >1.5, platelets <100,000, elevated PTT (prothrombin time), failure to discontinue anticoagulant medication, or infection at site)
• Significant renal, cardiac or hepatic disease per discretion of the investigator
• A clinical decision made that indicates need for a partial or complete axillary node dissection
• American Society of Anesthesiologists class 4-5
• Known hypersensitivity and/or allergies to local anesthetics
• Chronic Opioid Use (daily or almost daily use of opioids for > 3 months)
• Participant refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pectoralis Blockade(PECs); Participants undergo pectoralis nerve block (PEC II) will received anesthesia between the pectoralis major and minor in the chest while lying flat.	Procedure: Pectoralis Blockade (PECs); Ten milliliters of 0.25% bupivacaine with 2.5 mcg/ml epinephrine will be deposited between the pectoralis major and minor (PECs I) and 20 cc of 0.25% bupivacaine with 2.5mcg/ml epinephrine deposited between the pectoralis minor and serratus anterior muscle.
Active Comparator: Paravertebral Blockade (PVB); Participants undergoing paravertebral nerve block (PVB) consisting of receiving anesthesia in the back while sitting upright.	Procedure: Paravertebral Blockade; 10cc of 0.25% bupivacaine with 2.5 mcg/ml epinephrine will be deposited at two levels (T3 and T5) per side while in the sitting position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption	Primary outcome will be total opioid consumption in 24 hours for Paravertebral Nerve Block vs. Pectoralis Nerve Block.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to perform the block	To compare the following perioperative variables (pre/intraoperative): time to perform the block.	4 hours
Pain score	To compare the following perioperative variables: pain score at time of PACU, POD 1, 7 and 30	30 days
Location of most severe pain	To compare the following perioperative variables location of most severe pain at PACU, POD 1, 7 and 30	30 days
Presence or absence of axillary pain	To compare the following perioperative variables: presence or absence of axillary pain at PACU, POD 1, 7 and 30	30 days
Presence and severity of muscle spasm	To compare the following perioperative variables : presence and severity of muscle spasm at PACU, POD 1, 7 and 30	30 days
Total muscle relaxant consumption	To compare the following perioperative variables: total muscle relaxant consumption at PACU, POD 1, 7 and 30	30 days
Total antiemetic consumption	To compare the following perioperative variables: total antiemetic consumption at PACU and POD 1	48 hours
Time in PACU and hospital duration	To compare the following perioperative variables : time in PACU and hospital duration	48 hours
Opioid consumption at POD 7 and 30	To compare the following perioperative variables : Opioid consumption at POD 7 and 30	30 days

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Elizabeth Wilson, MD, Anesthesiology Department, University of Wisonsin Hospital and Clinics, Madison, Wisconsin, United States,53792.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Trace Elements; Micronutrients; Iodine
• Other Study ID Numbers: 2018-0579; A530900 (Other Identifier: UW Madison); NCI-2018-01743 (Other Identifier: NCI); UW17141 (Other Identifier: UWCCC); SMPH/ANESTHESIOLOGY/ANESTHESIO (Other Identifier: UW Madison); Protocol Version 9/12/2019 (Other Identifier: UW Madison)

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No