Pain, Chest, Pain, Postoperative
Conditions
Brief summary
The goals of this study are as follows: 1. to confirm the safe dosing of ropivacaine for the erector spinae plane block 2. develop a pharmacokinetic profile of the erector spinae plane block, which will help demonstrate how quickly and how closely toxic levels are reached when a routine dose of ropivacaine is given for this nerve block 3. assess numbness created by the erector spinae block when routine doses are administered
Interventions
0.25% ropivacaine administered through a nerve catheter
DRUGRopivacaine 0.2%-NaCl 0.9% Injectable Solution
0.2% ropivacaine administered through a nerve catheter
Sponsors
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant's age is greater than 18 years 2. Participant is undergoing a primary coronary artery bypass grafting surgery or heart valve replacement that requires a midline sternotomy incision 3. Participant's surgery is being performed by Dr. Vig Kasirajan
Exclusion criteria
1. Diagnosis of cirrhosis, hepatitis, primary sclerosing cholangitis 2. Abnormal liver function tests demonstrated by lab results 3. Allergy to lidocaine, ropivacaine, or midazolam 4. Morbid obesity, defined as body mass index greater than 40 5. Existing skin neuropathy on the chest or back 6. Body weight less than 50 kg 7. Participant is not able to provide verbal feedback, such as when the participant develops altered mental status or requires prolonged mechanical ventilation and sedation 8. Participant remains intubated on post-operative day 1 9. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 28 hours | The maximum concentration of serum ropivacaine after pre-determined dose is delivered through the ESP nerve catheter |
| Tmax | 28 hours | The time elapsed from initial ropivacaine administration to Cmax |
| Area of analgesia | 4 hours | The area of numbness experienced in the chest wall; measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders |
| Duration of analgesia | 4 hours | The duration of numbness to the chest wall; start time will be when the local anesthetic bolus is given, and end time will be when the participant reports the resolution of chest wall numbness |
Countries
United States
Outcome results
None listed