Postoperative Pain
Conditions
Brief summary
This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.
Interventions
DRUGLidocaine
DRUGKetamine
OTHERSaline
Sponsors
Beth Israel Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and Female \>/= 18 years of age Patients undergoing first-time fusion surgery or surgery to revise a prior fusion Able to read, write and speak in English, and able to give informed consent for the study
Exclusion criteria
Any disease associated with major organ dysfunction renal dysfunction hepatic dysfunction cardiac dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | postoperative day 1 - 3 | The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Ketamine infused at 0.25 mg/kg/hour.
Ketamine | 12 |
| Lidocaine Lidocaine infused at 0.5 mg/kg/hour.
Lidocaine | 11 |
| Ketamine and Lidocaine Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine
Ketamine | 12 |
| Placebo Placebo (saline) given to compare usual treatment against active agents in post operative pain management. | 11 |
| Total | 46 |
Baseline characteristics
| Characteristic | Ketamine | Lidocaine | Ketamine and Lidocaine | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 11 Participants | 12 Participants | 11 Participants | 46 Participants |
| Age, Continuous | 55.8 years STANDARD_DEVIATION 11.85 | 55.16 years STANDARD_DEVIATION 16.23 | 50.3 years STANDARD_DEVIATION 11.5 | 56.3 years STANDARD_DEVIATION 12.7 | 54.39 years STANDARD_DEVIATION 13.08 |
| Region of Enrollment United States | 12 participants | 11 participants | 12 participants | 11 participants | 46 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 8 Participants | 8 Participants | 31 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 12 | 2 / 11 | 6 / 12 | 6 / 11 |
| serious Total, serious adverse events | 1 / 12 | 0 / 11 | 3 / 12 | 1 / 11 |
Outcome results
Primary
Pain Intensity
The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).
Time frame: postoperative day 1 - 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine | Pain Intensity | 6.29 units on a scale | Standard Deviation 2.42 |
| Lidocaine | Pain Intensity | 5.76 units on a scale | Standard Deviation 2.25 |
| Ketamine and Lidocaine | Pain Intensity | 5.51 units on a scale | Standard Deviation 2.6 |
| Placebo | Pain Intensity | 6.40 units on a scale | Standard Deviation 2.59 |