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

Phase 2

Completed

• Conditions: Thoracic Surgery
• Interventions: Procedure: Serratus anterior plane block; Procedure: Sham serratus anterior plane block

• Registration Number: NCT04238455
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-22
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-23
• Status Verified: 2024-11
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Serratus anterior plane block	Serratus anterior plane block plus usual care
Control Group	Sham serratus anterior plane block	Sham serratus anterior plane block plus usual car

Primary Outcome Measures

Name	Time	Method
number of patients requiring opioids	within 24 hours post-operation	Assessment of this outcome will be performed by abstracting total dosage of opioids administered during this time period from the electronic medical record (EMR). Opioid dosages will be converted to intravenous morphine sulfate equivalent.

Trial Locations

Locations (6)

Memorial Sloan Kettering Nassau (Consent only); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Monmouth (Consent only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Commack (Consent Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (Consent only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Bergen (Consent only ); 🇺🇸 Montvale, New Jersey, United States