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Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

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ClinicalTrials.gov Identifier: NCT03859635
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Yar Yeap, Indiana University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Thoracic Acute Pain Procedure: Ultrasound Guided LB Erector Spinae Plane Block Procedure: Ultrasound Guided SB Erector Spinae Plane Block Procedure: Surgeon Infiltration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients are randomized into one of three groups:

  1. Ultrasound guided LB Erector Spinae Plane Block with 20ml of Exparel and 10ml 0.25% bupivacaine
  2. Ultrasound guided SB Erector Spinae Plane Block with 30ml 0.5% bupivacaine
  3. Surgeon Infiltration under video guidance with 20ml of Exparel and 10ml of 0.25% bupivacaine
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 7, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group #1
Ultrasound guided Liposomal Bupivacaine Erector Spinae Block
Procedure: Ultrasound Guided LB Erector Spinae Plane Block
All the erector spinae plane blocks will be placed preoperatively using Liposomal Bupivacaine. 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.
Other Name: Liposomal Bupivacaine

Active Comparator: Group #2
Ultrasound guided Standard Bupivacaine Erector Spinae Block
Procedure: Ultrasound Guided SB Erector Spinae Plane Block
All the erector spinae plane blocks will be placed preoperatively using Standard Bupivacaine. 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.
Other Name: Standard Bupivacaine

Active Comparator: Group #3
Surgeon Infiltration
Procedure: Surgeon Infiltration
SI group - at the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.
Other Name: SI




Primary Outcome Measures :
  1. The Primary endpoint of this study will be VAS pain score at 24 hours [ Time Frame: Pain scores will be measured 24 hours after surgery ]
    The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  2. The Primary endpoint of this study will be VAS pain score at.48 hours [ Time Frame: Pain scores will be measured 48 hours after surgery ]
    The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain


Secondary Outcome Measures :
  1. Secondary endpoint includes total opioid consumption at 72 hours [ Time Frame: Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.] ]
    Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements


Other Outcome Measures:
  1. 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, mild, moderate, or severe

  2. 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 and alert, quietly awake, asleep and arousable, or deep sleep.

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859635


Contacts
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Contact: Angie Plummer, LPN 317-944-7239 plummera@iupui.edu
Contact: Lyla S Farlow, LPN 317-948-9804 lychrist@iupui.edu

Locations
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United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Yar Yeap, MD    317-274-0275    yyeap@iupui.edu   
Contact: Angie m Plummer, LPN CCRP    317-274-0277    plummera@iupui.edu   
Sponsors and Collaborators
Indiana University

Publications of Results:
Other Publications:

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Responsible Party: Yar Yeap, Assistant Professor of Clinical Anesthesiology. Director, Acute Pain Service, Indiana University
ClinicalTrials.gov Identifier: NCT03859635     History of Changes
Other Study ID Numbers: 1809656804
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yar Yeap, Indiana University:
acute pain
VATS
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents