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Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

Primary Purpose

Pain, Postoperative, Thoracic, Acute Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivacaine
Bupivacaine, 0.25%
Bupivacaine, 0.5%
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring acute pain, VATS

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Ultrasound guided Liposomal Bupivacaine Erector Spinae Block

Ultrasound guided Standard Bupivacaine Erector Spinae Block

Surgeon Infiltration

Arm Description

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.

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.

At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.

Outcomes

Primary Outcome Measures

The Primary endpoint of this study will be VAS pain score at 24 hours
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
The Primary endpoint of this study will be VAS pain score at.48 hours
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

Secondary endpoint includes total opioid consumption at 72 hours
Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements
Average Nausea scores over 72 hours
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
Average Sedation scores over 72 hours
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.
Subjects overall satisfaction scores at hour 24
Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores
Subjects overall satisfaction scores at hour 48
Subjects will be followed up at 48 hours post operatively by a study team

Full Information

First Posted
February 28, 2019
Last Updated
August 14, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03859635
Brief Title
Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
November 6, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Thoracic, Acute Pain
Keywords
acute pain, VATS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized into one of three groups: Ultrasound guided LB Erector Spinae Plane Block with 20ml of Exparel and 10ml 0.25% bupivacaine Ultrasound guided SB Erector Spinae Plane Block with 30ml 0.5% bupivacaine Surgeon Infiltration under video guidance with 20ml of Exparel and 10ml of 0.25% bupivacaine
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided Liposomal Bupivacaine Erector Spinae Block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ultrasound guided Standard Bupivacaine Erector Spinae Block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgeon Infiltration
Arm Type
Active Comparator
Arm Description
At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Intervention Description
20 ml
Intervention Type
Drug
Intervention Name(s)
Bupivacaine, 0.25%
Intervention Description
10 ml
Intervention Type
Drug
Intervention Name(s)
Bupivacaine, 0.5%
Intervention Description
30 ml
Primary Outcome Measure Information:
Title
The Primary endpoint of this study will be VAS pain score at 24 hours
Description
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
Time Frame
Pain scores will be measured 24 hours after surgery
Title
The Primary endpoint of this study will be VAS pain score at.48 hours
Description
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
Time Frame
Pain scores will be measured 48 hours after surgery
Secondary Outcome Measure Information:
Title
Secondary endpoint includes total opioid consumption at 72 hours
Description
Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements
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.]
Title
Average Nausea scores over 72 hours
Description
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
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
Title
Average Sedation scores over 72 hours
Description
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.
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.]
Title
Subjects overall satisfaction scores at hour 24
Description
Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores
Time Frame
post operatively at hour 24
Title
Subjects overall satisfaction scores at hour 48
Description
Subjects will be followed up at 48 hours post operatively by a study team
Time Frame
post operatively at hour 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yar Yeap, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures

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