Erector Spinae Plane Block Versus Paravertebral Block in Mastectomy
Ultrasound-guided Thoracic Paravertebral Block Versus Ultrasound-guided Thoracic Erector Spinae Plane Block for Pain Management After Unilateral Total Mastectomy: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Paravertebral Block
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.
|
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.
|
|
Experimental: Erector Spinae Plane Block
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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: 2 hours after surgery
|
Pain score via Numeric Rating Scale (0-10)
|
2 hours after surgery
|
|
Opioid Use
Time Frame: 24 hours after surgery
|
Cumulative opioid consumption in oral morphine equivalents (mg)
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: 6, 12, 24, and 48 hours after surgery
|
Pain scores via Numeric Rating Scale (0-10)
|
6, 12, 24, and 48 hours after surgery
|
|
Opioid morbidity
Time Frame: 2, 6, 12, 24, and 48 hours after surgery
|
Any evidence of opioid-related morbidity or adverse effects
|
2, 6, 12, 24, and 48 hours after surgery
|
|
Procedural morbidity
Time Frame: 2, 6, 12, 24, and 48 hours after surgery
|
Any evidence of procedure-related morbidity (i.e.- with paravertebral block and erector spinae plane block)
|
2, 6, 12, 24, and 48 hours after surgery
|
|
Time
Time Frame: preoperative
|
Total time (in minutes) needed to perform the block (paravertebral or erector spinae plane block)
|
preoperative
|
Collaborators and Investigators
Investigators
- Principal Investigator: John C Alexander, MD, University of Texas
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 012018-081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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