Ultrasound-Guided Serratus Anterior Plane Block for Additional Pain Relief After Lung Surgery

NCT ID: NCT04238455

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2024-11-15

Brief Summary

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The purpose of this study is to see if an anesthesia technique called serratus anterior plane block may provide additional pain relief for the chest wall after lung surgery. The study will evaluate the effect the serratus anterior plane block technique has on the need for opioids after surgery,the level of pain during recovery, and other aspects of recovery, like whether the patient has nausea and their ability to breathe deeply. The effects of the serratus anterior plane block will be compared to the effects of an inactive (sham) block.

Detailed Description

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Conditions

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Thoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a two-arm randomized study of chest wall nerve blocks for postoperative analgesia after elective minimally invasive lung resection. The two study groups are: (1) usual care plus serratus anterior plane block (treatment arm), and (2) usual care plus sham serratus anterior plane block (control arm).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control Group

Sham serratus anterior plane block plus usual car

Group Type SHAM_COMPARATOR

Sham serratus anterior plane block

Intervention Type PROCEDURE

The serratus anterior plane block will be performed by the anesthesiology team just prior to emergence from general anesthesia.

Treatment Group

Serratus anterior plane block plus usual care

Group Type ACTIVE_COMPARATOR

Serratus anterior plane block

Intervention Type PROCEDURE

The serratus anterior plane block will be performed by the anesthesiology team just prior to emergence from general anesthesia.

Interventions

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Sham serratus anterior plane block

The serratus anterior plane block will be performed by the anesthesiology team just prior to emergence from general anesthesia.

Intervention Type PROCEDURE

Serratus anterior plane block

The serratus anterior plane block will be performed by the anesthesiology team just prior to emergence from general anesthesia.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patients ≥ 18 years of age who are capable of giving consent. English language proficiency is required.
* Undergoing elective minimally invasive (VATS or RATS) anatomic lung resection (segmentectomy or lobectomy) without an epidural.

Exclusion Criteria

* Pregnancy (Patients must have a negative pregnancy test within 30 days of the operation)
* History of documented anaphylaxis or contraindication to local anesthetics
* History of ipsilateral thoracic surgery. Ipsilateral thoracic surgery indicates any previous thoracoscopic or open (i.e. via thoracotomy) pleural biopsy, lung resection, esophageal surgery, chest wall resection, or other thoracic surgery within the chest cavity. This does not include image-guided lung biopsy. Note: Mediport placement and other procedures performed by a surgeon/proceduralist NOT within the chest cavity are not excluded. Likewise, patients with a history of ipsilateral breast surgery are also not excluded. The purpose is to exclude patients who may have had injury to the intercostal nerves from previous surgery or who have surgically altered anatomy of the hemithorax.
* Patients undergoing bilateral procedures
* Weight \< 50 kg
* Chronic sustained-release opioid use for \> 2 weeks duration (in the 30 days prior to surgery)
* Significant cognitive impairment or documented psychological impairment
* American Society of Anesthesiologists (ASA) physical status \> 3
* Patients may also be excluded from the study if the block is deemed not technically feasible (this may be determined intraoperatively).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Jackson, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen (Consent only )

Montvale, New Jersey, United States

Site Status

Memorial Sloan Kettering Commack (Consent Only)

Commack, New York, United States

Site Status

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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19-470

Identifier Type: -

Identifier Source: org_study_id

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