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

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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery
• Intervention / Treatment: Procedure: Sham serratus anterior plane block; Procedure: Serratus anterior plane block

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth (Consent Only)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (Consent only )
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack (Consent Only)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (Consent Only)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau (Consent Only)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Jacob Jackson, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: segmentectomy; lobectomy; Serratus Anterior Plane Block; 19-470
• Other Study ID Numbers: 19-470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No