Paravertebral Versus Pectoralis Block for Post Mastectomy Pain
Primary Purpose
Pain, Postoperative, Post-Mastectomy Chronic Pain Syndrome, Opioid Use
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pectoralis Blockade (PECs)
Paravertebral Blockade
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin Hospital and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pectoralis Blockade(PECs)
Paravertebral Blockade (PVB)
Arm Description
Participants undergo pectoralis nerve block (PEC II) will received anesthesia between the pectoralis major and minor in the chest while lying flat.
Participants undergoing paravertebral nerve block (PVB) consisting of receiving anesthesia in the back while sitting upright.
Outcomes
Primary Outcome Measures
Total Opioid Consumption
Primary outcome will be total opioid consumption in 24 hours for Paravertebral Nerve Block vs. Pectoralis Nerve Block.
Secondary Outcome Measures
time to perform the block
To compare the following perioperative variables (pre/intraoperative): time to perform the block.
Pain score
To compare the following perioperative variables: pain score at time of PACU, POD 1, 7 and 30
Location of most severe pain
To compare the following perioperative variables location of most severe pain at PACU, POD 1, 7 and 30
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
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
Total muscle relaxant consumption
To compare the following perioperative variables: total muscle relaxant consumption at PACU, POD 1, 7 and 30
Total antiemetic consumption
To compare the following perioperative variables: total antiemetic consumption at PACU and POD 1
Time in PACU and hospital duration
To compare the following perioperative variables :
time in PACU and hospital duration
Opioid consumption at POD 7 and 30
To compare the following perioperative variables : Opioid consumption at POD 7 and 30
Full Information
NCT ID
NCT03656679
First Posted
August 17, 2018
Last Updated
April 27, 2021
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT03656679
Brief Title
Paravertebral Versus Pectoralis Block for Post Mastectomy Pain
Official Title
A Comparison of the Paravertebral Block Versus Pectoralis Block in Controlling Bilateral Post-mastectomy Pain in Setting of Tissue Expander Placement
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
insufficient participant population per COVID-19
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Post-Mastectomy Chronic Pain Syndrome, Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessor will be provided with de-identified data for analysis
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pectoralis Blockade(PECs)
Arm Type
Active Comparator
Arm Description
Participants undergo pectoralis nerve block (PEC II) will received anesthesia between the pectoralis major and minor in the chest while lying flat.
Arm Title
Paravertebral Blockade (PVB)
Arm Type
Active Comparator
Arm Description
Participants undergoing paravertebral nerve block (PVB) consisting of receiving anesthesia in the back while sitting upright.
Intervention Type
Procedure
Intervention Name(s)
Pectoralis Blockade (PECs)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Paravertebral Blockade
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Opioid Consumption
Description
Primary outcome will be total opioid consumption in 24 hours for Paravertebral Nerve Block vs. Pectoralis Nerve Block.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
time to perform the block
Description
To compare the following perioperative variables (pre/intraoperative): time to perform the block.
Time Frame
4 hours
Title
Pain score
Description
To compare the following perioperative variables: pain score at time of PACU, POD 1, 7 and 30
Time Frame
30 days
Title
Location of most severe pain
Description
To compare the following perioperative variables location of most severe pain at PACU, POD 1, 7 and 30
Time Frame
30 days
Title
Presence or absence of axillary pain
Description
To compare the following perioperative variables: presence or absence of axillary pain at PACU, POD 1, 7 and 30
Time Frame
30 days
Title
Presence and severity of muscle spasm
Description
To compare the following perioperative variables :
presence and severity of muscle spasm at PACU, POD 1, 7 and 30
Time Frame
30 days
Title
Total muscle relaxant consumption
Description
To compare the following perioperative variables: total muscle relaxant consumption at PACU, POD 1, 7 and 30
Time Frame
30 days
Title
Total antiemetic consumption
Description
To compare the following perioperative variables: total antiemetic consumption at PACU and POD 1
Time Frame
48 hours
Title
Time in PACU and hospital duration
Description
To compare the following perioperative variables :
time in PACU and hospital duration
Time Frame
48 hours
Title
Opioid consumption at POD 7 and 30
Description
To compare the following perioperative variables : Opioid consumption at POD 7 and 30
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Wilson, MD
Organizational Affiliation
Anesthesiology Department, University of Wisonsin Hospital and Clinics, Madison, Wisconsin, United States,53792.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Paravertebral Versus Pectoralis Block for Post Mastectomy Pain
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