Efficacy Between Serratus Plane Block And Local Infiltration In Vats

September 11, 2020 updated by: Yan Lai, Icahn School of Medicine at Mount Sinai

Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Mount Sinai West Hospital
      • New York, New York, United States, 10019
        • Mount Sinai St. Luke's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA (American Society of Anesthesiology) class I-IV
  • age 81-75

Exclusion 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Serratus Plane Group
Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
Drug: Bupivacaine
20 cc 0.5%
Drug: Bupivacaine liposome
133mg liposomal bupivacaine
PLACEBO_COMPARATOR: Placebo Group
Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
Drug: Bupivacaine liposome
133mg liposomal bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Opioid Consumption
Time Frame: up to 24 hours post procedure
The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.
up to 24 hours post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Dose of Narcotic Administration
Time Frame: up to 24 hours post procedure
Time to first dose of narcotic administration post procedure
up to 24 hours post procedure
PACU Length of Stay
Time Frame: average 3-4 hours post procedure
The length of stay post procedure in the PACU
average 3-4 hours post procedure
ICU Length of Stay
Time Frame: up to 40 hours post procedure
The length of stay post procedure in the or ICU
up to 40 hours post procedure
Visual Analogue Score (VAS)
Time Frame: up to 24 hours post procedure
Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain)
up to 24 hours post procedure
Patient Satisfaction Score
Time Frame: up to 24 hours post procedure
Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied)
up to 24 hours post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Yan Lai, MD, MPH, cahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (ACTUAL)

August 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 17-1294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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