The investigators are conducting this study to find out if intravenous (injected through the vein) infusion of lidocaine and ketamine administered with general anesthesia is as effective as a paravertebral block in lessening pain after surgery and that both of these techniques are superior to general anesthesia alone in reducing pain immediately after surgery and in the long-term.
Participants will be randomized into one of three study groups; Group 1 - Paravertebral Group - ropivacaine is injected near the spine before surgery. Midazolam and fentanyl are administered intravenously for sedation. Group 2 - Lidocaine/Ketamine - General anesthesia with lidocaine and ketamine administered intravenously throughout your surgery and for 60 minutes after surgery. Group 3 - General Anesthesia Alone. General anesthesia with placebo administered intravenously throughout surgery and for 60 minutes after surgery. All participants will rate their pain on a scale from 0 to 10 after surgery and on days 1 and 2 after surgery. Participants are called 3 and 6 months after surgery for pain and quality of life assessments
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation
Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg).
placebo
Cleveland Clinic/Hillcrest Hospital
Mayfield Heights, Ohio, United States
Postoperative Opioid Consumption in Oral Oxycodone Equivalents
The cumulative opioid consumption after surgery until the end of second postoperative day.
Time frame: 2 days after surgery
Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents
The cumulative opioid consumption is calculated as fentanyl equivalent
Time frame: From admission to the end of surgery
Time From the End of Surgery to Readiness for Hospital Discharge.
Time frame: Until hospital discharge, assessed up to 6 months
Pain Scores on Numerical Rating Scale
Numerical Rating Scales is a measurement of pain ranging from 0 to 10 (11 point scale), where 0 is equal to no pain and 10 is equal to worst possible pain. Pain scores were measured in PACU, first and second postoperative mornings.
Time frame: After surgery until the second postoperative mornings.
Postoperative Nausea
Number of patients who had postoperative nausea or vomiting were recorded.
Time frame: After surgery until the second postoperative day.
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