Clinical trial NCT04238455: Ultrasound-Guided Serratus Anterior Plane Block for Additional Pain Relief After Lung Surgery
Official title: Addition of Ultrasound-Guided Serratus Anterior Plane Block to an Enhanced Recovery Pathway for Thoracoscopic Lung Resection: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thoracic Surgery
Keywords: Serratus Anterior Plane Block
segmentectomy
lobectomy
19-470
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: number of patients requiring opioids
timeFrame: within 24 hours post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jacob Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References: