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

Study Overview
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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.

Official Title
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Addition of Ultrasound-Guided Serratus Anterior Plane Block to an Enhanced Recovery Pathway for Thoracoscopic Lung Resection: A Randomized Trial

Conditions
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Thoracic Surgery

Intervention / Treatment
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* Procedure: Sham serratus anterior plane block
* Procedure: Serratus anterior plane block


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Group<br>Sham serratus anterior plane block plus usual car | Procedure: Sham serratus anterior plane block<br>* The serratus anterior plane block will be performed by the anesthesiology team just prior to emergence from general anesthesia.<br>|
| Active Comparator: Treatment Group<br>Serratus anterior plane block plus usual care | Procedure: Serratus anterior plane block<br>* The serratus anterior plane block will be performed by the anesthesiology team just prior to emergence from general anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients requiring opioids | 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. | within 24 hours post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serratus Anterior Plane Block, segmentectomy, lobectomy, 19-470