Postoperative PainPhase 4NCT03490006
Erector Spinae Plane Block Versus Paravertebral Block in Mastectomy
A Phase 4 study testing Erector Spinae Plane Block and Paravertebral Block in people with Postoperative Pain, run by University of Texas Southwestern Medical Center.
Trial summary
In this randomized, controlled, observer-blinded study the investigators plan to evaluate ultrasound-guided thoracic paravertebral block (TPVB) and ultrasound-guided thoracic erector spinae plane (TESP) block for postoperative pain management after unilateral total mastectomy without immediate reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plane Block and Paravertebral Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Oct 2020
- Phase
- Phase 4
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Criteria for Inclusion of Subjects:
- Female and male ASA physical status 1-3 scheduled for unilateral total mastectomy without immediate reconstruction
- Age 18-80 years old
- Able to participate personally or by legal representative in informed consent in English or Spanish
Criteria for Exclusion of Subjects:
- History of relevant drug allergy
- Age less than 18 or greater than 80 years
- Chronic opioid use or drug abuse
- Significant psychiatric disturbance
- Inability to understand the study protocol
- Refusal to provide written consent
About this study
Official title: Ultrasound-guided Thoracic Paravertebral Block Versus Ultrasound-guided Thoracic Erector Spinae Plane Block for Pain Management After Unilateral Total Mastectomy: a Randomized Controlled Trial
In this randomized, controlled, observer-blinded study the investigators plan to evaluate ultrasound-guided thoracic paravertebral block (TPVB) and ultrasound-guided thoracic erector spinae plane (TESP) block for postoperative pain management after unilateral total mastectomy without immediate reconstruction.
Read the detailed description
Despite substantial advances in our understanding of the pathophysiology of pain and availability of newer analgesic techniques postoperative pain is not always effectively treated. Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Currently, postoperative pain is commonly treated with systemic opioids, which are associated with numerous adverse effects including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and respiratory depression. Use of regional and local anesthesia has been shown to reduce opioid requirements and opioid-related side effects. Therefore, their use has been emphasized. The advent of ultrasound guided regional anesthesia has brought more precision to these techniques, including the ability to visualize the anatomy, perform real-time navigation, and direct observation of local anesthetic spread, as it allows a greater degree of sensory and motor blockade. Thoracic paravertebral block (TPVB) has been used for analgesia of the thoracic wall since it was first described in 1905. A relatively recent alternative to the TPVB is the thoracic erector spinae plane (TESP) block, which involves the ultrasound-guided injection of local anesthetic into the interfascial plane deep to the erector spinae muscle at the level of the transverse process. It results in a loss of somatic sensory sensation across multiple unilateral dermatomes due to local anesthetic mediated blockade of the dorsal and ventral rami of the spinal nerve roots. It is increasingly being used due to ease of placing the block and a perception of greater safety. It has been shown to provide pain relief from rib fractures, thoracotomy, and chronic neuropathic pain of the chest wall. However, to date, TESP block has not been compared with TPVB in regards to analgesia with mastectomy surgery, which has been extensively studied.
The investigators hypothesize that TESP block will provide similar (i.e., non-inferior) analgesia compared to TPVB block while reducing the cumulative consumption of oral morphine equivalents during the 24h post-operative period. The two co-primary aims of the study are to compare a) pain scores at 2h post-operative period, and b) cumulative consumption of oral morphine equivalents during the 24h post-operative period. Secondary objectives include comparison between the group in terms of pain scores at 6, 12, 24, and 48 hours post-operatively, as well as block-related morbidity (e.g.- pneumothorax), time to perform each block, and opioid-related adverse effects (e.g.- postoperative nausea and vomiting).
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plane Block, Paravertebral Block
- Keywords
- regional anesthesia, postoperative pain, mastectomy, erector spinae plane block, paravertebral block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
A relatively recent alternative to the paravertebral block is the thoracic erector spinae plane block, which involves the ultrasound-guided injection of local anesthetic into the interfascial plane deep to the erector spinae muscle at the level of the transverse process. It results in a loss of somatic sensory sensation across multiple unilateral dermatomes due to local anesthetic mediated blockade of the dorsal and ventral rami of the spinal nerve roots. It is increasingly being used due to ease of placing the block and a perception of greater safety. It has been shown to provide pain relief from rib fractures, thoracotomy, and chronic neuropathic pain of the chest wall. However, to date, erector spinae plane block has not been compared with paravertebral block in regards to analgesia with mastectomy surgery, which has been extensively studied.
Paravertebral BlockProcedure or surgery
Paravertebral block is a classic regional anesthesia technique that has been in use for over 100 years. It is performed by the injection of local anesthetic into the space between the costotransverse ligament and parietal pleura resulting in blockade of ipsilateral intercostal nerves. It results in a loss of somatic sensation over multiple unilateral dermatomes.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block | Active comparator | For this arm, the initial level will be at T3-4 and an out-of-plane technique to guide the needle tip to a point between the costotransverse ligament and the parietal pleura between the visualized transverse processes. Then, a few milliliters of 0.5% ropivacaine will be injected slowly to displace the pleura ventrally as the paravertebral space fills with local anesthetic. After negative aspiration, the rest of 0.5% ropivacaine (total 10 ml) will be injected in 5 ml increments to further fill the paravertebral space. The procedure will then be repeated in the same exact fashion at the T5-6 level. We will observe local anesthetic spread under real-time ultrasound imaging. Receives: Procedure: Paravertebral Block |
| Erector Spinae Plane Block | Experimental | For this arm, the needle tip will be directed under ultrasound guidance using an in-plane technique towards the T5 transverse process until the needle tip contacts os. Then, a few milliliters of ropivacaine will be injected slowly to separate the plane between the erector spinae muscle and the transverse process. After negative aspiration, the rest of the 0.5% ropivacaine will be injected (total 20ml) Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain score via Numeric Rating Scale (0-10)
Measured: 2 hours after surgery
Opioid Use
Cumulative opioid consumption in oral morphine equivalents (mg)
Measured: 24 hours after surgery
Secondary outcomes (4)
Pain
Pain scores via Numeric Rating Scale (0-10)
Measured: 6, 12, 24, and 48 hours after surgery
Opioid morbidity
Any evidence of opioid-related morbidity or adverse effects
Measured: 2, 6, 12, 24, and 48 hours after surgery
Procedural morbidity
Any evidence of procedure-related morbidity (i.e.- with paravertebral block and erector spinae plane block)
Measured: 2, 6, 12, 24, and 48 hours after surgery
Time
Total time (in minutes) needed to perform the block (paravertebral or erector spinae plane block)
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study startAug 2018 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: Insufficient resources to complete study requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms. One group will receive erector spinae plane block, and the other will receive paravertebral block.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Alexander, University of Texas Southwestern Medical Center
- Investigators
- John C Alexander, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490006
- Sponsor's protocol ID
- STU 012018-081
- Status last verified
- Oct 2018
- First submitted
- 20 Mar 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Thoracic Paravertebral Block Versus Ultrasound-guided Thoracic Erector Spinae Plane Block for Pain Management After Unilateral Total Mastectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03490006
- Acronym / sponsor ID
- STU 012018-081
- Conditions
- Postoperative Pain
- Keywords
- regional anesthesia, postoperative pain, mastectomy, erector spinae plane block, paravertebral block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient resources to complete study requirements
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 6 Apr 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.
In this randomized, controlled, observer-blinded study the investigators plan to evaluate ultrasound-guided thoracic paravertebral block (TPVB) and ultrasound-guided thoracic erector spinae plane (TESP) block for postoperative pain management after unilateral total mastectomy without immediate reconstruction.
Detailed description
Despite substantial advances in our understanding of the pathophysiology of pain and availability of newer analgesic techniques postoperative pain is not always effectively treated. Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Currently, postoperative pain is commonly treated with systemic opioids, which are associated with numerous adverse effects including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and respiratory depression. Use of regional and local anesthesia has been shown to reduce opioid requirements and opioid-related side effects. Therefore, their use has been emphasized. The advent of ultrasound guided regional anesthesia has brought more precision to these techniques, including the ability to visualize the anatomy, perform real-time navigation, and direct observation of local anesthetic spread, as it allows a greater degree of sensory and motor blockade. Thoracic paravertebral block (TPVB) has been used for analgesia of the thoracic wall since it was first described in 1905. A relatively recent alternative to the TPVB is the thoracic erector spinae plane (TESP) block, which involves the ultrasound-guided injection of local anesthetic into the interfascial plane deep to the erector spinae muscle at the level of the transverse process. It results in a loss of somatic sensory sensation across multiple unilateral dermatomes due to local anesthetic mediated blockade of the dorsal and ventral rami of the spinal nerve roots. It is increasingly being used due to ease of placing the block and a perception of greater safety. It has been shown to provide pain relief from rib fractures, thoracotomy, and chronic neuropathic pain of the chest wall. However, to date, TESP block has not been compared with TPVB in regards to analgesia with mastectomy surgery, which has been extensively studied.
The investigators hypothesize that TESP block will provide similar (i.e., non-inferior) analgesia compared to TPVB block while reducing the cumulative consumption of oral morphine equivalents during the 24h post-operative period. The two co-primary aims of the study are to compare a) pain scores at 2h post-operative period, and b) cumulative consumption of oral morphine equivalents during the 24h post-operative period. Secondary objectives include comparison between the group in terms of pain scores at 6, 12, 24, and 48 hours post-operatively, as well as block-related morbidity (e.g.- pneumothorax), time to perform each block, and opioid-related adverse effects (e.g.- postoperative nausea and vomiting).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms. One group will receive erector spinae plane block, and the other will receive paravertebral block.
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block | Active comparator | Procedure: Paravertebral BlockFor this arm, the initial level will be at T3-4 and an out-of-plane technique to guide the needle tip to a point between the costotransverse ligament and the parietal pleura between the visualized transverse processes. Then, a few milliliters of 0.5% ropivacaine will be injected slowly to displace the pleura ventrally as the paravertebral space fills with local anesthetic. After negative aspiration, the rest of 0.5% ropivacaine (total 10 ml) will be injected in 5 ml increments to further fill the paravertebral space. The procedure will then be repeated in the same exact fashion at the T5-6 level. We will observe local anesthetic spread under real-time ultrasound imaging. |
| Erector Spinae Plane Block | Experimental | Procedure: Erector Spinae Plane BlockFor this arm, the needle tip will be directed under ultrasound guidance using an in-plane technique towards the T5 transverse process until the needle tip contacts os. Then, a few milliliters of ropivacaine will be injected slowly to separate the plane between the erector spinae muscle and the transverse process. After negative aspiration, the rest of the 0.5% ropivacaine will be injected (total 20ml) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Erector Spinae Plane BlockA relatively recent alternative to the paravertebral block is the thoracic erector spinae plane block, which involves the ultrasound-guided injection of local anesthetic into the interfascial plane deep to the erector spinae muscle at the level of the transverse process. It results in a loss of somatic sensory sensation across multiple unilateral dermatomes due to local anesthetic mediated blockade of the dorsal and ventral rami of the spinal nerve roots. It is increasingly being used due to ease of placing the block and a perception of greater safety. It has been shown to provide pain relief from rib fractures, thoracotomy, and chronic neuropathic pain of the chest wall. However, to date, erector spinae plane block has not been compared with paravertebral block in regards to analgesia with mastectomy surgery, which has been extensively studied. | Procedure or surgery | Erector Spinae Plane Block |
| Paravertebral BlockParavertebral block is a classic regional anesthesia technique that has been in use for over 100 years. It is performed by the injection of local anesthetic into the space between the costotransverse ligament and parietal pleura resulting in blockade of ipsilateral intercostal nerves. It results in a loss of somatic sensation over multiple unilateral dermatomes. | Procedure or surgery | Paravertebral Block |
Primary outcome
Pain
Time frame: 2 hours after surgery
Pain score via Numeric Rating Scale (0-10)
Opioid Use
Time frame: 24 hours after surgery
Cumulative opioid consumption in oral morphine equivalents (mg)
4 secondary outcomes
Pain
Time frame: 6, 12, 24, and 48 hours after surgery
Opioid morbidity
Time frame: 2, 6, 12, 24, and 48 hours after surgery
Procedural morbidity
Time frame: 2, 6, 12, 24, and 48 hours after surgery
Time
Time frame: preoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- 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.
John C Alexander, MD principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erector Spinae Plane Block and Paravertebral Block in people with Postoperative Pain, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain (time frame: 2 hours after surgery). The study lists 2 primary outcomes in all. 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 12 Oct 2018.