A Phase 4 interventional study of Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally and Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally in Pain, Postoperative and Pain, Chest, sponsored by Virginia Commonwealth University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Virginia Commonwealth University · Phase 4, Interventional, and Supportive care
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.
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.
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Exclusion Criteria:
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
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 bilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours bilaterally.
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.
Median Effective Dose
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)
Time frame: 6.5 hours
Change in pain rating
Self reported pain rating on a 0-10 scale where 0 is no pain and 10 is pain as bad as it can be
Time frame: From just before to 30 minutes after a bolus is administered
Change in heart rate
Heart rate measured using a heart rate monitor
Time frame: From just before to 30 minutes after a bolus is administered
Blood pressure
Blood pressure measured using a blood pressure monitor
Time frame: From just before to 30 minutes after a bolus is administered
Change in percent oxygen saturation of hemoglobin
Pulse oximetry reading from a monitor
Time frame: From just before to 30 minutes after a bolus is administered
Changes in electrocardiogram tracing
Monitoring for changes in electrical conduction in the heart as monitored by the continuous 5 lead electrocardiogram tracing, watching for any side effects.
Time frame: From just before a bolus is administered to 6.5 hours
Dermatomal coverage
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
Time frame: From just before to 30 minutes after a bolus is administered
Opioid consumption
Total opioid medication consumption during the study period
Time frame: 6.5 hours
Non-narcotic pain medication consumption
Total non-narcotic pain medicine consumption during the study period
Time frame: 6.5 hours
Plan to share: No
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This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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