TerminatedPhase 4NCT03642457
Official study title

Efficacy Between Serratus Plane Block And Local Infiltration In Vats

Study summary

Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon. Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores. The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance. The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBupivacaine and Bupivacaine liposome

The study team can explain what participation involves.

Who it may be forEarly-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 30, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 4

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Icahn School of Medicine at Mount Sinai

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 4
Sponsor
Icahn School of Medicine at Mount Sinai
Interventions being studied
Drug: Bupivacaine; Drug: Bupivacaine liposome
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • ASA (American Society of Anesthesiology) class I-IV
  • age 81-75
Reasons someone may not be able to joinExclusion criteria
  • ASA class V
  • morbid obesity
  • patient refusal
  • patients with chronic pain or on pain medications
  • allergy to LA
  • patients receiving any additional regional techniques
  • coagulopathy
  • patients receiving systemic anticoagulation
  • local infection
  • procedures anticipated to last more than 5 hours.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mount Sinai St. Luke's HospitalNew York, New York
  • Mount Sinai West HospitalNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 30, 2020. Always confirm current availability with the study team.

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