Erector Spinae Plane Block Versus Paravertebral Block in Mastectomy

NCT03490006 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: STU 012018-081
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Keywords

regional anesthesia; postoperative pain; mastectomy; erector spinae plane block; paravertebral block

Outcome Measures

Primary Outcomes (2)

• Pain

  Pain score via Numeric Rating Scale (0-10)

  2 hours after surgery

• Opioid Use

  Cumulative opioid consumption in oral morphine equivalents (mg)

  24 hours after surgery

Secondary Outcomes (4)

• Pain

  6, 12, 24, and 48 hours after surgery

• Opioid morbidity

  2, 6, 12, 24, and 48 hours after surgery

• Procedural morbidity

  2, 6, 12, 24, and 48 hours after surgery

• Time

  preoperative

Study Arms (2)

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.

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)

Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane Block 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.

Erector Spinae Plane Block

Paravertebral Block 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.

Paravertebral Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• John C Alexander, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The practitioner must know which block to perform, and the patient will be able to deduce which block was performed because paravertebral requires two injections, and erector spinae requires only one injection. The outcomes assessor will not know which group each patient is in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two parallel arms. One group will receive erector spinae plane block, and the other will receive paravertebral block.

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 6, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share