Erector Spinae Plane Block Versus Paravertebral Block in Mastectomy

Phase 4

Withdrawn

• Conditions: Postoperative Pain
• Interventions: Procedure: Erector Spinae Plane Block; Procedure: Paravertebral Block

• Registration Number: NCT03490006
• Lead Sponsor: University of Texas Southwestern Medical Center

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).

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-06
• Study Start: 2018-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-12
• Primary Completion: 2020-08
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block	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)
Paravertebral Block	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.

Primary Outcome Measures

Name	Time	Method
Pain	2 hours after surgery	Pain score via Numeric Rating Scale (0-10)
Opioid Use	24 hours after surgery	Cumulative opioid consumption in oral morphine equivalents (mg)

Secondary Outcome Measures

Name	Time	Method
Pain	6, 12, 24, and 48 hours after surgery	Pain scores via Numeric Rating Scale (0-10)
Opioid morbidity	2, 6, 12, 24, and 48 hours after surgery	Any evidence of opioid-related morbidity or adverse effects
Procedural morbidity	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)
Time	preoperative	Total time (in minutes) needed to perform the block (paravertebral or erector spinae plane block)