Trial Outcomes & Findings for Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery (NCT NCT01983020)
NCT ID: NCT01983020
Last Updated: 2017-05-15
Results Overview
The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
46 participants
Primary outcome timeframe
postoperative day 1 - 3
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
Ketamine
Ketamine infused at 0.25 mg/kg/hour.
Ketamine
|
Lidocaine
Lidocaine infused at 0.5 mg/kg/hour.
Lidocaine
|
Ketamine and Lidocaine
Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine
Ketamine
|
Placebo
Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery
Baseline characteristics by cohort
| Measure |
Ketamine
n=12 Participants
Ketamine infused at 0.25 mg/kg/hour.
Ketamine
|
Lidocaine
n=11 Participants
Lidocaine infused at 0.5 mg/kg/hour.
Lidocaine
|
Ketamine and Lidocaine
n=12 Participants
Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine
Ketamine
|
Placebo
n=11 Participants
Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
55.16 years
STANDARD_DEVIATION 16.23 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
54.39 years
STANDARD_DEVIATION 13.08 • n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
12 participants
n=5 Participants
|
11 participants
n=4 Participants
|
46 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: postoperative day 1 - 3The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).
Outcome measures
| Measure |
Ketamine
n=12 Participants
Ketamine infused at 0.25 mg/kg/hour.
Ketamine
|
Lidocaine
n=11 Participants
Lidocaine infused at 0.5 mg/kg/hour.
Lidocaine
|
Ketamine and Lidocaine
n=12 Participants
Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine
Ketamine
|
Placebo
n=11 Participants
Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
|
|---|---|---|---|---|
|
Pain Intensity
|
6.29 units on a scale
Standard Deviation 2.42
|
5.76 units on a scale
Standard Deviation 2.25
|
5.51 units on a scale
Standard Deviation 2.60
|
6.40 units on a scale
Standard Deviation 2.59
|
Adverse Events
Ketamine
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Lidocaine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ketamine and Lidocaine
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketamine
n=12 participants at risk
Ketamine infused at 0.25 mg/kg/hour.
Ketamine
|
Lidocaine
n=11 participants at risk
Lidocaine infused at 0.5 mg/kg/hour.
Lidocaine
|
Ketamine and Lidocaine
n=12 participants at risk
Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine
Ketamine
|
Placebo
n=11 participants at risk
Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
2/12 • Number of events 2
|
0.00%
0/11
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
2/12 • Number of events 8
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Low Blood Pressure
|
0.00%
0/12
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Diplopia
|
8.3%
1/12 • Number of events 4
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/11
|
Other adverse events
| Measure |
Ketamine
n=12 participants at risk
Ketamine infused at 0.25 mg/kg/hour.
Ketamine
|
Lidocaine
n=11 participants at risk
Lidocaine infused at 0.5 mg/kg/hour.
Lidocaine
|
Ketamine and Lidocaine
n=12 participants at risk
Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine
Ketamine
|
Placebo
n=11 participants at risk
Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Cold Sweats
|
8.3%
1/12 • Number of events 2
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/11
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
9.1%
1/11 • Number of events 2
|
|
General disorders
Sedation
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
18.2%
2/11 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
0.00%
0/12
|
18.2%
2/11 • Number of events 2
|
0.00%
0/12
|
0.00%
0/11
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/12
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Eye disorders
Blurred Vision
|
0.00%
0/12
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Lightheadedness
|
0.00%
0/12
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Headache
|
0.00%
0/12
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Itching
|
0.00%
0/12
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place