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出境医 / 临床实验 / Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters

Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters

Study Description
Brief Summary:
This study would like to identify the best starting dose and infusion rate for nerve blocks and nerve catheters related to the erector spinae plane block that can improve functional status and pain control on cardiac surgery patients and minimize the necessity for opioid pain control using a continuous reassessment model.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Pain, Chest Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally Phase 4

Detailed Description:
The study will continue taking steps in helping to identify the role erector spinae plane nerve blocks have in thoracic surgery. This is a relatively new nerve block (first identified and described in 2016) and the studies that have been done and the case series that have been reported have been very promising in supporting its role in thoracic surgery. As it is a plane block (not around a specific nerve but in a general area), larger volumes and doses often have to be used in these sorts of blocks (such as a transverses abdominalis plane block) to get good spread of the local anesthetic in the plane to reach the desired nerves that pass through this plane with one injection. Our hospital has been doing these blocks for patients as a standard of care for them, but this study will take a closer look to see if there is an optimal dose and volume of medicine to improve patients' functional status and pain control to minimize the need for opioids. The study will use a continuous reassessment model to determine the optimal dose.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Bilateral catheters
patients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions)
 Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally
Variable initial post-operative dose of 10cc to 40cc bilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours bilaterally.
Experimental: Single catheter
patients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies)
 Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally
Variable initial post-operative dose of 10cc to 40cc unilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours unilaterally.
Outcome Measures
Primary Outcome Measures :
  1. Median Effective Dose [ Time Frame: 6.5 hours ]
    Dose at which 50% of patients achieve a clinically significant nerve block after a single bolus and after periodic programmed boluses of Ropivacaine as represented by either an adequate decrease in sensation of the chest (covering at least 5 dermatomes) or an improvement in vital capacity breaths (of 500 mL or more)


Secondary Outcome Measures :
  1. Change in pain rating [ Time Frame: From just before to 30 minutes after a bolus is administered ]
    Self reported pain rating on a 0-10 scale where 0 is no pain and 10 is pain as bad as it can be

  2. Change in heart rate [ Time Frame: From just before to 30 minutes after a bolus is administered ]
    Heart rate measured using a heart rate monitor

  3. Blood pressure [ Time Frame: From just before to 30 minutes after a bolus is administered ]
    Blood pressure measured using a blood pressure monitor

  4. Change in percent oxygen saturation of hemoglobin [ Time Frame: From just before to 30 minutes after a bolus is administered ]
    Pulse oximetry reading from a monitor

  5. Changes in electrocardiogram tracing [ Time Frame: From just before a bolus is administered to 6.5 hours ]
    Monitoring for changes in electrical conduction in the heart as monitored by the continuous 5 lead electrocardiogram tracing, watching for any side effects.

  6. Dermatomal coverage [ Time Frame: From just before to 30 minutes after a bolus is administered ]
    The area of numbness experienced in the chest wall as measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders

  7. Opioid consumption [ Time Frame: 6.5 hours ]
    Total opioid medication consumption during the study period

  8. Non-narcotic pain medication consumption [ Time Frame: 6.5 hours ]
    Total non-narcotic pain medicine consumption during the study period


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing planned thoracotomies and sternotomies for cardiothoracic surgery who will be taken to the cardiac surgery ICU postoperatively

Exclusion Criteria:

  • BMI >40
  • infection at the proposed catheter site
  • ongoing sepsis/bacteremia
  • patient unable to sit up for the procedure
  • patients requiring significant vasopressor support (>1 vasopressor)
  • patient refusal
  • less than 18 years of age (they are managed in the pediatric ICU rather than the Cardiac Surgery ICU)
Contacts and Locations

Locations
Layout table for location information
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Layout table for investigator information
Principal Investigator: Bryant Tran, MD Virginia Commonwealth University
Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE July 23, 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019) 		Median Effective Dose [ Time Frame: 6.5 hours ]
Dose at which 50% of patients achieve a clinically significant nerve block after a single bolus and after periodic programmed boluses of Ropivacaine as represented by either an adequate decrease in sensation of the chest (covering at least 5 dermatomes) or an improvement in vital capacity breaths (of 500 mL or more)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Change in pain rating [ Time Frame: From just before to 30 minutes after a bolus is administered ]
    Self reported pain rating on a 0-10 scale where 0 is no pain and 10 is pain as bad as it can be
  • Change in heart rate [ Time Frame: From just before to 30 minutes after a bolus is administered ]
    Heart rate measured using a heart rate monitor
  • Blood pressure [ Time Frame: From just before to 30 minutes after a bolus is administered ]
    Blood pressure measured using a blood pressure monitor
  • Change in percent oxygen saturation of hemoglobin [ Time Frame: From just before to 30 minutes after a bolus is administered ]
    Pulse oximetry reading from a monitor
  • Changes in electrocardiogram tracing [ Time Frame: From just before a bolus is administered to 6.5 hours ]
    Monitoring for changes in electrical conduction in the heart as monitored by the continuous 5 lead electrocardiogram tracing, watching for any side effects.
  • Dermatomal coverage [ Time Frame: From just before to 30 minutes after a bolus is administered ]
    The area of numbness experienced in the chest wall as measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders
  • Opioid consumption [ Time Frame: 6.5 hours ]
    Total opioid medication consumption during the study period
  • Non-narcotic pain medication consumption [ Time Frame: 6.5 hours ]
    Total non-narcotic pain medicine consumption during the study period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
Official Title  ICMJE Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
Brief Summary This study would like to identify the best starting dose and infusion rate for nerve blocks and nerve catheters related to the erector spinae plane block that can improve functional status and pain control on cardiac surgery patients and minimize the necessity for opioid pain control using a continuous reassessment model.
Detailed Description The study will continue taking steps in helping to identify the role erector spinae plane nerve blocks have in thoracic surgery. This is a relatively new nerve block (first identified and described in 2016) and the studies that have been done and the case series that have been reported have been very promising in supporting its role in thoracic surgery. As it is a plane block (not around a specific nerve but in a general area), larger volumes and doses often have to be used in these sorts of blocks (such as a transverses abdominalis plane block) to get good spread of the local anesthetic in the plane to reach the desired nerves that pass through this plane with one injection. Our hospital has been doing these blocks for patients as a standard of care for them, but this study will take a closer look to see if there is an optimal dose and volume of medicine to improve patients' functional status and pain control to minimize the need for opioids. The study will use a continuous reassessment model to determine the optimal dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pain, Postoperative
  • Pain, Chest
Intervention  ICMJE
  • Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally
    Variable initial post-operative dose of 10cc to 40cc bilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours bilaterally.
  • Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally
    Variable initial post-operative dose of 10cc to 40cc unilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours unilaterally.
Study Arms  ICMJE
  • Experimental: Bilateral catheters
    patients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions)
    Intervention: Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally
  • Experimental: Single catheter
    patients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies)
    Intervention: Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 22, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		80
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients undergoing planned thoracotomies and sternotomies for cardiothoracic surgery who will be taken to the cardiac surgery ICU postoperatively

Exclusion Criteria:

  • BMI >40
  • infection at the proposed catheter site
  • ongoing sepsis/bacteremia
  • patient unable to sit up for the procedure
  • patients requiring significant vasopressor support (>1 vasopressor)
  • patient refusal
  • less than 18 years of age (they are managed in the pediatric ICU rather than the Cardiac Surgery ICU)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961048
Other Study ID Numbers  ICMJE HM20014242
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bryant Tran, MD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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