Erector Spinae Plane Block Versus Paravertebral Block in Mastectomy

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03490006
• Other study ID #: STU 012018-081
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 2018
• Est. completion date: October 2020

Study information

• Verified date: October 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain score via Numeric Rating Scale (0-10)	2 hours after surgery
Primary	Opioid Use	Cumulative opioid consumption in oral morphine equivalents (mg)	24 hours after surgery
Secondary	Pain	Pain scores via Numeric Rating Scale (0-10)	6, 12, 24, and 48 hours after surgery
Secondary	Opioid morbidity	Any evidence of opioid-related morbidity or adverse effects	2, 6, 12, 24, and 48 hours after surgery
Secondary	Procedural morbidity	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
Secondary	Time	Total time (in minutes) needed to perform the block (paravertebral or erector spinae plane block)	preoperative