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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04238455
• Other study ID #: 19-470
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 22, 2020
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 93
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Commack (Consent Only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent only )	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent only)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center