Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

February 7, 2025 updated by: Yar Yeap, Indiana University

Randomized Prospective Study Comparing Exparel Erector Spinae Plane Block vs Simple Bupivacaine Erector Spinae Plane Block vs Exparel Surgeon Infiltration for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery

The study is comparing the difference between erector spinae block and surgeon infiltration after VATS (Video Assisted Thoracoscopic Surgery). The outcomes measured are pain scores, opioid usage, opioid side effects, and patient satisfaction.We are also also studying the effectiveness of liposomal bupivacaine (EXPAREL) in a block by randomizing patients to both EXPAREL erector spinae block and simple bupivacaine erector spinae block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 120 subjects will be randomized by a computer program into three groups (40 per group): The primary investigator will inform the anesthesiologist who will be doing the block as to what group the patients are randomized to. The research staff completing the patients assessments will be blinded to the randomization.

For the LB group (Ultrasound guided LB Erector Spinae Plane Block), patients should receive a total of 10ml 0.25% bupivacaine plus 20ml Exparel® (15ml at T4 and 15ml at T8) For the SB group (Ultrasound guided SB Erector Spinae Plane Block), patients should receive a total of 30ml 0.5% bupivacaine. (15ml at T4 and 15ml at T8) For the SI group (under video guidance) injected by surgeon using 10ml 0.25% bupivacaine plus 20ml Exparel

All the erector spinae plane blocks will be placed preoperatively after sedation, before intubation and prior to surgery. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.

For the ESP block, an ultrasound probe is used to visualize the ES musculature about 3 cm laterally from the spinous process. In a cephalad-to-caudad direction advance the needle and inject the anesthetic in the interfacial plane deep to the ES muscles. Confirm positioning by visualization of needle tip and elevation of ES muscles off the transverse process with anesthetic injection. Injection will be performed at T4 and T8 level.

Surgeon infiltration is performed intraoperatively under direct thoracoscopic guidance. The intercostal space will be visualized and injected with LB. Typically, T4 through T8 are infiltrated with the anesthetic mixture.

All patients will be placed on ERAS protocol, which is our standard of practice.

Opioid usage after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the surgery.

All patients will receive a phone call 6 months after surgery for assessment for chronic post-surgical pain. Patients will be assessed by a member of the research team over the phone. They will be assessed on their pain score and narcotic usage by using the Brief Pain Inventory. Study participation will conclude after the 6 month follow questionnaire has been completed.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

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
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University 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 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pt undergoing VATS including but not limited to wedge or lobectomy at Indiana University Hospital
  • ASA 1,2,3 or 4
  • Age 18 or older, male or female
  • Desires regional anesthesia for postoperative pain control

Exclusion criteria:

  • Any contraindication for Erector Spinae Plane block
  • History of substance abuse in the past 6 months which would include heroin, marijuana or any other illegal street drugs
  • Patient staying intubated after surgery
  • Patient (home dose) taking more than 30mg PO morphine equivalent per day
  • Known allergy or other contraindications to the study medications, which include dilaudid and bupivacaine.
  • Pts. scheduled for a pleurodesis, decortication or esophagectomy at Indiana University Hospital

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound guided Liposomal Bupivacaine Erector Spinae Block
All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.
Drug: Liposomal Bupivacaine
20 ml
Drug: Bupivacaine, 0.25%
10 ml
Active Comparator: Ultrasound guided Standard Bupivacaine Erector Spinae Block
All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.
Drug: Bupivacaine, 0.5%
30 ml
Active Comparator: Surgeon Infiltration
At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.
Drug: Liposomal Bupivacaine
20 ml
Drug: Bupivacaine, 0.25%
10 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest
Time Frame: 24 hours pain score at rest
The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
24 hours pain score at rest
The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement
Time Frame: 24 hours pain score with movement
The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
24 hours pain score with movement
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest
Time Frame: 48 hours pain score at rest
The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
48 hours pain score at rest
The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement
Time Frame: 48 hours pain score with movement
The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
48 hours pain score with movement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoint Includes Total Opioid Consumption at 72 Hours
Time Frame: Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.]
Opioid consumption between 48-72hr will be collected by a study team member per protocol time requirements
Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.]
Average Nausea Scores Over 72 Hours
Time Frame: Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as None=0, Mild=1, Moderate=2, Severe=3.
Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged
Average Sedation Scores Over 72 Hours
Time Frame: Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged.]
Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is Awake/Alert=0, Quietly Awake=1, Asleep but Arousable=2, or Deep Sleep=3
Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged.]
Subjects Overall Satisfaction Scores at Hour 24
Time Frame: post operatively at hour 24
Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4
post operatively at hour 24
Subjects Overall Satisfaction Scores at Hour 48
Time Frame: post operatively at hour 48
Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4
post operatively at hour 48
Secondary Endpoint Includes Total Opioid Consumption at 48 Hours
Time Frame: Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.]
Opioid consumption at 24-48hr post op will be collected by a study team member per protocol time requirements
Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.]
Secondary Endpoint Includes Total Opioid Consumption at 24 Hours
Time Frame: Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.]
Opioid consumption at 1-24 hr postop will be collected by a study team member per protocol time requirements
Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.]
Secondary Endpoint Includes Total Opioid Consumption at 1 Hour
Time Frame: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.]
Opioid consumption at 1hr will be collected by a study team member per protocol time requirements
Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.]

Collaborators and Investigators

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

Sponsor

Indiana University

Investigators

  • Principal Investigator: Yar Yeap, MD, Indiana University

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)

February 7, 2019

Primary Completion (Actual)

November 6, 2022

Study Completion (Actual)

November 7, 2022

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1809656804

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

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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