Trial Outcomes & Findings for Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain (NCT NCT00720330)
NCT ID: NCT00720330
Last Updated: 2019-03-12
Results Overview
The cumulative opioid consumption after surgery until the end of second postoperative day.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
2 days after surgery
Results posted on
2019-03-12
Participant Flow
Participant milestones
| Measure |
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
|
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).
|
Placebo
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
3
|
|
Overall Study
COMPLETED
|
5
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain
Baseline characteristics by cohort
| Measure |
Ropivacaine
n=5 Participants
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
|
Lidocaine/Ketamine
n=4 Participants
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).
|
Placebo
n=3 Participants
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 12 • n=5 Participants
|
52 years
STANDARD_DEVIATION 10 • n=7 Participants
|
53 years
STANDARD_DEVIATION 13 • n=5 Participants
|
50 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Weight
|
90 kg
STANDARD_DEVIATION 13 • n=5 Participants
|
77 kg
STANDARD_DEVIATION 14 • n=7 Participants
|
101 kg
STANDARD_DEVIATION 13 • n=5 Participants
|
88 kg
STANDARD_DEVIATION 15 • n=4 Participants
|
|
Height
|
176 cm
STANDARD_DEVIATION 10 • n=5 Participants
|
183 cm
STANDARD_DEVIATION 5 • n=7 Participants
|
179 cm
STANDARD_DEVIATION 13 • n=5 Participants
|
179 cm
STANDARD_DEVIATION 7 • n=4 Participants
|
PRIMARY outcome
Timeframe: 2 days after surgeryThe cumulative opioid consumption after surgery until the end of second postoperative day.
Outcome measures
| Measure |
Ropivacaine
n=5 Participants
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
|
Lidocaine/Ketamine
n=4 Participants
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).
|
Placebo
n=3 Participants
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo
|
|---|---|---|---|
|
Postoperative Opioid Consumption in Oral Oxycodone Equivalents
|
564 mg
Interval 0.0 to 2645.0
|
73 mg
Interval 30.0 to 170.0
|
1381 mg
Interval 25.0 to 2450.0
|
SECONDARY outcome
Timeframe: From admission to the end of surgeryThe cumulative opioid consumption is calculated as fentanyl equivalent
Outcome measures
| Measure |
Ropivacaine
n=5 Participants
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
|
Lidocaine/Ketamine
n=4 Participants
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).
|
Placebo
n=3 Participants
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo
|
|---|---|---|---|
|
Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents
|
100 mcg
Standard Deviation 50
|
113 mcg
Standard Deviation 25
|
134 mcg
Standard Deviation 58
|
SECONDARY outcome
Timeframe: Until hospital discharge, assessed up to 6 monthsOutcome measures
| Measure |
Ropivacaine
n=5 Participants
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
|
Lidocaine/Ketamine
n=4 Participants
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).
|
Placebo
n=3 Participants
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo
|
|---|---|---|---|
|
Time From the End of Surgery to Readiness for Hospital Discharge.
|
2.2 hours
Standard Deviation 0.3
|
3.8 hours
Standard Deviation 1.0
|
3.0 hours
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: After surgery until the second postoperative mornings.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.
Outcome measures
| Measure |
Ropivacaine
n=5 Participants
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
|
Lidocaine/Ketamine
n=4 Participants
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).
|
Placebo
n=3 Participants
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo
|
|---|---|---|---|
|
Pain Scores on Numerical Rating Scale
PACU
|
0.8 units on a scale
Standard Deviation 1.8
|
2.0 units on a scale
Standard Deviation 4.0
|
6.3 units on a scale
Standard Deviation 1.5
|
|
Pain Scores on Numerical Rating Scale
POD1
|
4.6 units on a scale
Standard Deviation 1.9
|
3.3 units on a scale
Standard Deviation 1.9
|
3.7 units on a scale
Standard Deviation 2.1
|
|
Pain Scores on Numerical Rating Scale
POD2
|
2.6 units on a scale
Standard Deviation 0.5
|
2.8 units on a scale
Standard Deviation 1.3
|
2 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: After surgery until the second postoperative day.Number of patients who had postoperative nausea or vomiting were recorded.
Outcome measures
| Measure |
Ropivacaine
n=5 Participants
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
|
Lidocaine/Ketamine
n=4 Participants
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).
|
Placebo
n=3 Participants
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo
|
|---|---|---|---|
|
Postoperative Nausea
|
2 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Ropivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine/Ketamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place