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Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure. (VATS)

Primary Purpose

Video Assisted Thoracoscopic Surgery, Pain, Postoperative, Pain, Acute

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion)
US Guided Paravertebral Catheter (0.2% ropivicaine bolus)
Thoracic Epidural (0.125% bupivicaine/hydromorphone)
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Video Assisted Thoracoscopic Surgery focused on measuring VATS, pain

Eligibility Criteria

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

Inclusion Criteria:

  • Pt undergoing VATS procedure 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 Thoracic Epidural or Paravertebral block
  • History of substance abuse in the past 6 months
  • Patient staying intubated after surgery
  • Known allergy or other contraindications to the study medications , which include dilaudid, bupivacaine, ropivacaine

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

Group #1

Group #2

Group #3

Arm Description

US Guided Single Shot Paravertebral Block

US Guided Paravertebral Catheter

Thoracic Epidural

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 "units on 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 scores 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"units on a scale" scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

Secondary Outcome Measures

Secondary Endpoint Includes Total Intravenous 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

Full Information

First Posted
March 22, 2017
Last Updated
January 7, 2021
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03151434
Brief Title
Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.
Acronym
VATS
Official Title
Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (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 purpose of this study is to compare three different pain control methods on subjects who are scheduled to undergo VATS (video-assisted thoracoscopic surgery) procedures. The study will compare their pain scores, narcotic needs, patient satisfaction scores, and narcotic side effects.
Detailed Description
All patients will be consented on the morning of surgery. All the thoracic epidurals and ultrasound-guided paravertebral blocks will be placed preoperatively. The procedures will be done using sterile technique with masks, hats, and sterile gloves. 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. Thoracic epidurals will be placed using the Arrow thoracic epidural kit. The epidural will be placed at the appropriate level to cover the entry site for the VATS procedure. Placement will be determined by anatomical landmarks. The epidural needle will be advanced toward the epidural space utilizing a Paramedian approach and loss-of-resistance technique. A sterile catheter will then be secured in place and the epidural infusion will be started at the end of the case. Ultrasound guided paravertebral catheter and single shot paravertebral block will be accomplished using an ultrasound transducer at the thoracic level. This will be done using an in-plane or out-of-plane approach, at the discretion of the anesthesia staff performing the procedure. Then a needle will be inserted the needle into the paravertebral space and local anesthetic injected. Then a catheter will be placed within the injectate and secured in place in the case of the paravertebral catheter. The 0.2% Ropivicaine will be delivered by OnQ pump. General anesthesia will be induced and the patient will be placed in the lateral position for the VATS procedure. The patients will be intubated with dual lumen endotracheal tubes and placed on one-lung ventilation for the procedure. All patients will receive intravenous patient-controlled analgesia (PCA hydromorphone) post-operatively for breakthrough pain. They will also be scheduled on PO acetaminophen. PO oxycodone PRN will be started on POD 1 once patients tolerate diet. Opioid usage at 1,24,48,72 hours 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 epidural or PVB. Patients will be encouraged to ambulate on postoperative day 1 under supervision. All catheters will be removed by APS (Acute Pain Service) while patients are still in the hospital. APS will continue to follow the patients until catheter removal. Patient's hospital length of stay and readmission rate will be recorded from NSQIP (National Surgical Quality Improvement Program) data. 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
Video Assisted Thoracoscopic Surgery, Pain, Postoperative, Pain, Acute
Keywords
VATS, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients randomized to epidural, single shot paravertebral block, and paravertebral catheter
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group #1
Arm Type
Active Comparator
Arm Description
US Guided Single Shot Paravertebral Block
Arm Title
Group #2
Arm Type
Active Comparator
Arm Description
US Guided Paravertebral Catheter
Arm Title
Group #3
Arm Type
Active Comparator
Arm Description
Thoracic Epidural
Intervention Type
Drug
Intervention Name(s)
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion)
Other Intervention Name(s)
US Guided Single Shot Paravertebral Block
Intervention Description
Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
Intervention Type
Drug
Intervention Name(s)
US Guided Paravertebral Catheter (0.2% ropivicaine bolus)
Other Intervention Name(s)
US Guided Paravertebral Catheter
Intervention Description
Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Thoracic Epidural (0.125% bupivicaine/hydromorphone)
Intervention Description
Epidural catheter will be placed in the thoracic region prior to surgery.
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 "units on 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 scores 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"units on a scale" 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 Intravenous 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.
Other Pre-specified Outcome Measures:
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 0=none, 1=mild, 2=moderate, or 3=severe
Time Frame
Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.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 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep.
Time Frame
Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.
Title
Subjects Overall Satisfaction Scores
Description
Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
Time Frame
post operatively at hour 24
Title
Subjects Overall Satisfaction Scores
Description
Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. Scores will be recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
Time Frame
post operatively at hour 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pt undergoing VATS procedure 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 Thoracic Epidural or Paravertebral block History of substance abuse in the past 6 months Patient staying intubated after surgery Known allergy or other contraindications to the study medications , which include dilaudid, bupivacaine, ropivacaine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yar Yeap, MD
Organizational Affiliation
Indiana University Hospital
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
Citations:
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Citation
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Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.

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