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Completed

NCT Number: NCT04238455

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sham serratus anterior plane block

Procedure

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

Serratus Anterior Plane Block

Procedure

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2020
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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