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Enrollment challenges prohibited study progression.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Active Comparator | Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation |
|
| Lidocaine/ketamine | Active Comparator | Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery. |
|
| Placebo | Placebo Comparator | General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Opioid Consumption in Oral Oxycodone Equivalents | The cumulative opioid consumption after surgery until the end of second postoperative day. | 2 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents | The cumulative opioid consumption is calculated as fentanyl equivalent | From admission to the end of surgery |
| Time From the End of Surgery to Readiness for Hospital Discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Cummings, MD | The Cleveland Clinic | Principal Investigator |
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic/Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine | Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation ropivacaine: 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 |
| FG001 | Lidocaine/Ketamine | Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery. Lidocaine/Ketamine: 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). |
| FG002 | Placebo | General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine | Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation ropivacaine: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Opioid Consumption in Oral Oxycodone Equivalents | The cumulative opioid consumption after surgery until the end of second postoperative day. | Posted | Mean | Full Range | mg | 2 days after surgery |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ropivacaine | Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation ropivacaine: 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberta Johnson | Cleveland Clinic | 216-444-9950 | johnsor13@ccf.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D008012 | Lidocaine |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Lidocaine/Ketamine | Drug | 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 | Other | placebo |
|
| 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. | After surgery until the second postoperative mornings. |
| Postoperative Nausea | Number of patients who had postoperative nausea or vomiting were recorded. | After surgery until the second postoperative day. |
| BG001 | Lidocaine/Ketamine | Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery. Lidocaine/Ketamine: 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). |
| BG002 | Placebo | General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery placebo: placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| OG002 | Placebo | General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery placebo: placebo |
|
|
| Secondary | Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents | The cumulative opioid consumption is calculated as fentanyl equivalent | Posted | Mean | Standard Deviation | mcg | From admission to the end of surgery |
|
|
|
| Secondary | Time From the End of Surgery to Readiness for Hospital Discharge. | Posted | Mean | Standard Deviation | hours | Until hospital discharge, assessed up to 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | After surgery until the second postoperative mornings. |
|
|
|
| Secondary | Postoperative Nausea | Number of patients who had postoperative nausea or vomiting were recorded. | Posted | Count of Participants | Participants | After surgery until the second postoperative day. |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Lidocaine/Ketamine | Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery. Lidocaine/Ketamine: 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). | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Placebo | General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery placebo: placebo | 0 | 3 | 0 | 3 | 0 | 3 |
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| D000588 |
| Amines |
| D000083 | Acetanilides |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
|
| POD2 |
|