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

NCT04238455 | Completed Phase 2

• 1 other identifier: 19-470
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 6

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.

Conditions

Thoracic Surgery

Keywords

Serratus Anterior Plane Block; segmentectomy; lobectomy; 19-470

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group

SHAM COMPARATOR

Sham serratus anterior plane block plus usual car

Procedure: Sham serratus anterior plane block

Treatment Group

ACTIVE COMPARATOR

Serratus anterior plane block plus usual care

Procedure: Serratus anterior plane block

Interventions

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.

Control Group

Serratus anterior plane block PROCEDURE

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

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (6)

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent only )

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent Only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Jacob Jackson, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 23, 2020
• Study Start: January 22, 2020
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (6)