Pain, PostoperativeNCT03656679
Paravertebral Versus Pectoralis Block for Post Mastectomy Pain
A study testing Pectoralis Blockade (PECs) and Paravertebral Blockade in people with Pain, Postoperative and Post-Mastectomy Chronic Pain Syndrome, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Post-Mastectomy Chronic Pain Syndrome, Opioid Use
- What is being tested?
- Pectoralis Blockade (PECs) and Paravertebral Blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: 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.
Read the 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.
- Being tested
- Pectoralis Blockade (PECs), Paravertebral Blockade
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoralis Blockade (PECs)Procedure or surgery
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.
Paravertebral BlockadeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pectoralis Blockade(PECs) | Active comparator | Participants undergo pectoralis nerve block (PEC II) will received anesthesia between the pectoralis major and minor in the chest while lying flat. Receives: Procedure: Pectoralis Blockade (PECs) |
| Paravertebral Blockade (PVB) | Active comparator | Participants undergoing paravertebral nerve block (PVB) consisting of receiving anesthesia in the back while sitting upright. Receives: Procedure: Paravertebral Blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption
Primary outcome will be total opioid consumption in 24 hours for Paravertebral Nerve Block vs. Pectoralis Nerve Block.
Measured: 24 hours
Secondary outcomes (9)
time to perform the block
To compare the following perioperative variables (pre/intraoperative): time to perform the block.
Measured: 4 hours
Pain score
To compare the following perioperative variables: pain score at time of PACU, POD 1, 7 and 30
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days
Total muscle relaxant consumption
To compare the following perioperative variables: total muscle relaxant consumption at PACU, POD 1, 7 and 30
Measured: 30 days
Total antiemetic consumption
To compare the following perioperative variables: total antiemetic consumption at PACU and POD 1
Measured: 48 hours
Time in PACU and hospital duration
To compare the following perioperative variables :
time in PACU and hospital duration
Measured: 48 hours
Opioid consumption at POD 7 and 30
To compare the following perioperative variables : Opioid consumption at POD 7 and 30
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start18 Oct 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Why it stopped: insufficient participant population per COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Wilson, MD, Principal investigator, Anesthesiology Department, University of Wisonsin Hospital and Clinics, Madison, Wisconsin, United States,53792.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656679
- Sponsor's protocol ID
- 2018-0579
- Other IDs
- NCI-2018-01743, UW17141, A530900, SMPH/ANESTHESIOLOGY/ANESTHESIO, Protocol Version 9/12/2019
- Status last verified
- Apr 2021
- First submitted
- 17 Aug 2018
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Paravertebral Block Versus Pectoralis Block in Controlling Bilateral Post-mastectomy Pain in Setting of Tissue Expander Placement
- ClinicalTrials.gov ID
- NCT03656679
- Acronym / sponsor ID
- 2018-0579
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient participant population per COVID-19
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Pectoralis Blockade(PECs) | Active comparator | Procedure: 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. |
| Paravertebral Blockade (PVB) | Active comparator | Procedure: Paravertebral BlockadeParticipants undergoing paravertebral nerve block (PVB) consisting of receiving anesthesia in the back while sitting upright. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Pectoralis Blockade(PECs) |
| Paravertebral Blockade10cc 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. | Procedure or surgery | Paravertebral Blockade (PVB) |
Primary outcome
Total Opioid Consumption
Time frame: 24 hours
Primary outcome will be total opioid consumption in 24 hours for Paravertebral Nerve Block vs. Pectoralis Nerve Block.
9 secondary outcomes
time to perform the block
Time frame: 4 hours
Pain score
Time frame: 30 days
Location of most severe pain
Time frame: 30 days
Presence or absence of axillary pain
Time frame: 30 days
Presence and severity of muscle spasm
Time frame: 30 days
Total muscle relaxant consumption
Time frame: 30 days
Total antiemetic consumption
Time frame: 48 hours
Time in PACU and hospital duration
Time frame: 48 hours
Opioid consumption at POD 7 and 30
Time frame: 30 days
Results and safety
The study was stopped early (reason given: insufficient participant population per COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Wilson, MD principal investigator
Anesthesiology Department, University of Wisonsin Hospital and Clinics, Madison, Wisconsin, United States,53792.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pectoralis Blockade (PECs) and Paravertebral Blockade in people with Pain, Postoperative and Post-Mastectomy Chronic Pain Syndrome, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient participant population per COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.