Erector Spinae Plane Block Versus Paravertebral Block in Mastectomy

NCT ID: NCT03490006

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2020-10-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Paravertebral Block

Intervention Type: PROCEDURE

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.

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)

Group Type: EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type: PROCEDURE

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.

Interventions

Erector Spinae Plane Block

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.

Intervention Type: PROCEDURE

Paravertebral Block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

John Alexander

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John C Alexander, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Other Identifiers

STU 012018-081

Identifier Type: -

Identifier Source: org_study_id