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Clinical Trials/NCT04238455
NCT04238455
Completed
Phase 2

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

Memorial Sloan Kettering Cancer Center6 sites in 1 country93 target enrollmentJanuary 22, 2020

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Thoracic Surgery
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
93
Locations
6
Primary Endpoint
number of patients requiring opioids
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2020
End Date
November 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

number of patients requiring opioids

Time Frame: 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.

Study Sites (6)

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