Pain, Chest, Pain, Postoperative
Conditions
Keywords
Erector Spinae, Cardiac Surgery, Regional Anesthesia
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.
Interventions
DRUGRopivacaine 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.
DRUGRopivacaine 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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Effective Dose | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate | From just before to 30 minutes after a bolus is administered | Heart rate measured using a heart rate monitor |
| Blood pressure | 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 | From just before to 30 minutes after a bolus is administered | Pulse oximetry reading from a monitor |
| Change in pain rating | 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 |
| Dermatomal coverage | 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 | 6.5 hours | Total opioid medication consumption during the study period |
| Non-narcotic pain medication consumption | 6.5 hours | Total non-narcotic pain medicine consumption during the study period |
| Changes in electrocardiogram tracing | 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. |
Countries
United States
Outcome results
None listed