Abdominal Hysterectomy (& Wertheim)
Conditions
Keywords
pain control, nausea, surgery recovery
Brief summary
This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations will be done through walking tests, pain and fatigue questionnaires and blood tests.
Detailed description
Subjects undergoing abdominal hysterectomy surgery are randomized into one of four groups: Intravenous Lidocaine, Intravenous Ketamine, Intravenous Lidocaine and Ketamine or Placebo. Subjects will perform a six-minute walk test prior to surgery and on the second day postoperatively. After surgery and on days 1 and 2 after surgery, subjects will rate their pain. On day 1 postoperatively, subjects will rate their fatigue. On postoperative days 1 and 2 incisional pain will be analysed using von Frey filaments. Two hours after surgery, 10 ml of venous blood will be sampled for cytokine analysis. Telephone follow up will take place 6 and 12 months postoperatively to access pain and quality of life.
Interventions
DRUGLidocaine
Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
DRUGPlacebo
Placebo boluses and infusions will be substituted
DRUGKetamine
Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
both Ketamine and Lidocaine will be given
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years old and less than 75 years years old * Horizontal abdominal incision
Exclusion criteria
* Emergency or urgent procedure * Preexisting chronic pain (at any site) requiring treatment * Contraindication to any study medication (ketamine or lidocaine) * History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.) * Significant hepatic (ALT or AST \> 2 times normal) or renal (serum creatinine \> 2 mg/dl) impairment * Seizure disorder requiring medication within past 2 years * Planned spinal or epidural anesthesia or analgesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two | postoperative day 2 | The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2 | Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain. |
| Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | intraoperative through postoperative day 2 | — |
| Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | 2 hours after surgery, on postoperative day 1 | — |
| Verbal Response Fatigue Score on Postoperative Day 1 | postoperative day 1 | Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue. |
Countries
United States
Participant flow
Pre-assignment details
This is a factorial study design with 64 patients randomized to 2 treatments each: lidocaine or placebo and ketamine or placebo. Each treatment was analyzed separately (i.e., lidocaine versus placebo and ketamine versus placebo separately). Though there are 4 distinct groups, the same 64 patients are in both lidocaine and ketamine analyses.
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine/Ketamine Intravenous Lidocaine and Ketamine Group -
Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours. Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters. | 15 |
| Lidocaine Intravenous lidocaine Group - A lidocaine is administered intravenously through out surgery and 24 hours after surgery.
Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. | 16 |
| Ketamine Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively. | 15 |
| Placebo A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
A placebo infusion will be substituted for the ketamine or Lidocaine not given | 16 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Ultram use | 1 | 0 | 0 | 0 |
| Overall Study | vertical incision | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Lidocaine/Ketamine | Lidocaine | Ketamine | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 7 | 46 years STANDARD_DEVIATION 7 | 46 years STANDARD_DEVIATION 9 | 47 years STANDARD_DEVIATION 8 | 46 years STANDARD_DEVIATION 8 |
| American Society of Anesthesiologists Physical Status A normal healthy patient | 0 participants | 0 participants | 2 participants | 0 participants | 2 participants |
| American Society of Anesthesiologists Physical Status A patient with mild systemic disease | 14 participants | 13 participants | 10 participants | 15 participants | 52 participants |
| American Society of Anesthesiologists Physical Status A patient with severe systemic disease | 1 participants | 3 participants | 3 participants | 1 participants | 8 participants |
| Body Mass Index | 28 kg per meters squared STANDARD_DEVIATION 6 | 29 kg per meters squared STANDARD_DEVIATION 6 | 29 kg per meters squared STANDARD_DEVIATION 10 | 28 kg per meters squared STANDARD_DEVIATION 6 | 29 kg per meters squared STANDARD_DEVIATION 7 |
| Preoperative 6-MWD | 318 m STANDARD_DEVIATION 47 | 320 m STANDARD_DEVIATION 44 | 304 m STANDARD_DEVIATION 41 | 338 m STANDARD_DEVIATION 52 | 320 m STANDARD_DEVIATION 47 |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 15 Participants | 16 Participants | 62 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | 16 / 16 | 16 / 16 | 15 / 15 | 15 / 15 |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 15 | 0 / 15 |
Outcome results
Primary
The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two
The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.
Time frame: postoperative day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine | The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two | 202 meters | Standard Deviation 66 |
| Nonlidocaine | The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two | 202 meters | Standard Deviation 73 |
| Ketamine | The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two | 193 meters | Standard Deviation 77 |
| Nonketamine | The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two | 210 meters | Standard Deviation 61 |
Comparison: The effect of lidocaine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.p-value: 0.9697.5% CI: [-52, 54]ANCOVA
Comparison: The effect of ketamine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.p-value: 0.5497.5% CI: [-65, 44]ANCOVA
Secondary
Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day
Time frame: 2 hours after surgery, on postoperative day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lidocaine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Vomiting, PACU | 6 percentage of participants |
| Lidocaine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Nausea, PACU | 32 percentage of participants |
| Lidocaine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Nausea, POD 1 | 55 percentage of participants |
| Lidocaine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Vomiting, POD 1 | 23 percentage of participants |
| Nonlidocaine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Vomiting, POD 1 | 16 percentage of participants |
| Nonlidocaine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Vomiting, PACU | 19 percentage of participants |
| Nonlidocaine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Nausea, PACU | 26 percentage of participants |
| Nonlidocaine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Nausea, POD 1 | 48 percentage of participants |
| Ketamine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Nausea, POD 1 | 53 percentage of participants |
| Ketamine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Nausea, PACU | 30 percentage of participants |
| Ketamine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Vomiting, PACU | 10 percentage of participants |
| Ketamine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Vomiting, POD 1 | 23 percentage of participants |
| Nonketamine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Nausea, POD 1 | 50 percentage of participants |
| Nonketamine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Nausea, PACU | 28 percentage of participants |
| Nonketamine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Vomiting, POD 1 | 16 percentage of participants |
| Nonketamine | Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day | Vomiting, PACU | 16 percentage of participants |
Comparison: Lidocaine versus nonlidocaine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.p-value: 0.5897.5% CI: [-0.28, 0.41]Chi-squared
Comparison: Ketamine versus nonketamine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.p-value: 0.8797.5% CI: [-0.32, 0.36]Chi-squared
Comparison: Lidocaine versus nonlidocaine on POD 1 (first postoperative day) nausea assessed using Pearson chi square test.p-value: 0.6197.5% CI: [-0.31, 0.44]Chi-squared
Comparison: Ketamine versus nonketamine on POD 1(first postoperative day) nausea assessed using Pearson chi square test.p-value: 0.7997.5% CI: [-0.34, 0.41]Chi-squared
Comparison: Lidocaine versus nonlidocaine on PACU (postoperative care unit) vomiting assessed using Pearson chi square test.p-value: 0.2697.5% CI: [-0.38, 0.12]Chi-squared
Comparison: Ketamine versus nonketamine on PACU (postoperative care unit) vomiting assessed using a Pearson chi square test.p-value: 0.7197.5% CI: [-0.31, 0.19]Chi-squared
Comparison: Lidocaine versus nonlidocaine on postoperative day 1 vomiting assessed using a Pearson chi square test.p-value: 0.5297.5% CI: [-0.23, 0.36]Chi-squared
Comparison: Ketamine versus nonketamine on postoperative day 1 vomiting assessed using Pearson chi square test.p-value: 0.4497.5% CI: [-0.22, 0.38]Chi-squared
Secondary
Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2
Time frame: intraoperative through postoperative day 2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lidocaine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | intraoperative | 20 milligram morphine sulfate equivalents |
| Lidocaine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative care unit | 20 milligram morphine sulfate equivalents |
| Lidocaine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative day 1 | 23 milligram morphine sulfate equivalents |
| Lidocaine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative day 2 | 10 milligram morphine sulfate equivalents |
| Nonlidocaine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative care unit | 23 milligram morphine sulfate equivalents |
| Nonlidocaine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative day 1 | 22 milligram morphine sulfate equivalents |
| Nonlidocaine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative day 2 | 6 milligram morphine sulfate equivalents |
| Nonlidocaine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | intraoperative | 20 milligram morphine sulfate equivalents |
| Ketamine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative day 1 | 21 milligram morphine sulfate equivalents |
| Ketamine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative care unit | 20 milligram morphine sulfate equivalents |
| Ketamine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative day 2 | 9 milligram morphine sulfate equivalents |
| Ketamine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | intraoperative | 20 milligram morphine sulfate equivalents |
| Nonketamine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative day 2 | 8 milligram morphine sulfate equivalents |
| Nonketamine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative care unit | 23 milligram morphine sulfate equivalents |
| Nonketamine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | intraoperative | 23 milligram morphine sulfate equivalents |
| Nonketamine | Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 | postoperative day 1 | 23 milligram morphine sulfate equivalents |
Comparison: Lidocaine versus nonlidocaine on intraoperative opioid consumption was assessed using the Wilcoxon rank sum test.p-value: 0.6397.5% CI: [-7, 7]Wilcoxon (Mann-Whitney)
Comparison: Ketamine versus nonketamine on intraoperative opioid consumption was assessed using a Wilcoxon rank sum test.p-value: 0.2797.5% CI: [-10, 5]Wilcoxon (Mann-Whitney)
Comparison: Lidocaine versus nonlidocaine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.p-value: 0.2897.5% CI: [-15, 5]Wilcoxon (Mann-Whitney)
Comparison: Ketamine versus nonketamine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.p-value: 0.2297.5% CI: [-15, 4]Wilcoxon (Mann-Whitney)
Comparison: Lidocaine versus nonlidocaine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.p-value: 0.7697.5% CI: [-13, 21]Wilcoxon (Mann-Whitney)
Comparison: Ketamine versus nonketamine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.p-value: 0.6697.5% CI: [-19, 14]Wilcoxon (Mann-Whitney)
Comparison: Lidocaine versus nonlidocaine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.p-value: 0.397.5% CI: [-5, 10]Wilcoxon (Mann-Whitney)
Comparison: Ketamine versus nonketamine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.p-value: 0.7997.5% CI: [-5, 8]Wilcoxon (Mann-Whitney)
Secondary
Verbal Response Fatigue Score on Postoperative Day 1
Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.
Time frame: postoperative day 1
Population: 11 patients had missing POD 1 fatigue scores (e.g., 11 for lidocaine vs. nonlidocaine and 11 for ketamine vs. nonketamine).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine | Verbal Response Fatigue Score on Postoperative Day 1 | 7.2 units on a scale | Standard Deviation 2.5 |
| Nonlidocaine | Verbal Response Fatigue Score on Postoperative Day 1 | 7.2 units on a scale | Standard Deviation 2.4 |
| Ketamine | Verbal Response Fatigue Score on Postoperative Day 1 | 7.4 units on a scale | Standard Deviation 2.6 |
| Nonketamine | Verbal Response Fatigue Score on Postoperative Day 1 | 7.0 units on a scale | Standard Deviation 2.3 |
Comparison: Lidocaine was compared to nonlidocaine on mean VRS fatigue score using a t test.p-value: 0.9697.5% CI: [-2.14, 2.2]t-test, 2 sided
Comparison: Ketamine was compared to nonketamine on mean VRS fatigue score using a t test.p-value: 0.5997.5% CI: [-1.8, 2.57]t-test, 2 sided
Secondary
Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2
Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.
Time frame: PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | PACU admit | 6.2 units on a scale | Standard Deviation 3.3 |
| Lidocaine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | PACU discharge | 4.0 units on a scale | Standard Deviation 2.3 |
| Lidocaine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | POD 1 | 4.0 units on a scale | Standard Deviation 1.8 |
| Lidocaine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | POD 2 | 3.1 units on a scale | Standard Deviation 1.7 |
| Nonlidocaine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | PACU discharge | 4.9 units on a scale | Standard Deviation 1.9 |
| Nonlidocaine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | POD 1 | 3.3 units on a scale | Standard Deviation 2.2 |
| Nonlidocaine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | POD 2 | 2.9 units on a scale | Standard Deviation 1.9 |
| Nonlidocaine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | PACU admit | 7.1 units on a scale | Standard Deviation 2.5 |
| Ketamine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | POD 1 | 3.7 units on a scale | Standard Deviation 2.2 |
| Ketamine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | PACU discharge | 4.6 units on a scale | Standard Deviation 2.4 |
| Ketamine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | POD 2 | 3.1 units on a scale | Standard Deviation 2.1 |
| Ketamine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | PACU admit | 6.4 units on a scale | Standard Deviation 3.4 |
| Nonketamine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | POD 2 | 2.8 units on a scale | Standard Deviation 1.4 |
| Nonketamine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | PACU discharge | 4.3 units on a scale | Standard Deviation 1.9 |
| Nonketamine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | PACU admit | 6.9 units on a scale | Standard Deviation 2.5 |
| Nonketamine | Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | POD 1 | 3.6 units on a scale | Standard Deviation 1.7 |
Comparison: Groups compared on VRS scores at PACU admit using a t test.p-value: 0.297.5% CI: [-3.3, 1.3]t-test, 2 sided
Comparison: Ketamine compared to placebo at PACU admit using a t testp-value: 0.5497.5% CI: [-2.8, 1.9]t-test, 2 sided
Comparison: Lidocaine versus nonlidocaine on pain severity at postoperative care unit discharge was assessed using a t test.p-value: 0.1197.5% CI: [-2.5, 0.8]t-test, 2 sided
Comparison: Ketamine versus nonketamine on postoperative care unit discharge pain severity was assessed using a t test.p-value: 0.5697.5% CI: [-1.4, 2]t-test, 2 sided
Comparison: Lidocaine versus nonlidocaine on postoperative day 1 pain severity assessed using a t test.p-value: 0.297.5% CI: [-0.9, 2.2]t-test, 2 sided
Comparison: Ketamine versus nonketamine on postoperative day 1 pain severity was assessed using a t test.p-value: 0.7997.5% CI: [-1.4, 1.7]t-test, 2 sided
Comparison: Lidocaine versus nonlidocaine on postoperative day 2 pain severity was assessed using a t test.p-value: 0.5597.5% CI: [-1.1, 1.7]t-test, 2 sided
Comparison: Ketamine versus nonketamine on postoperative day 2 pain severity was assessed using a t test.p-value: 0.4797.5% CI: [-1.1, 1.8]t-test, 2 sided