Knee Osteoarthritis, Arthroplasty Complications, Postoperative Pain
Conditions
Brief summary
The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee arthroplasty can be observed with the substitution of a post operative adductor canal block for a preoperative adductor canal block in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).
Interventions
DRUGDexamethasone
Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
DRUGAcetaminophen
1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
DRUGLyrica
Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
DRUGCelebrex
200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
DRUGMeloxicam
30mg administered via IV once postoperatively within 24 hours for pain and swelling
DRUGOxycodone
5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
DRUGRopivacaine
20 milliliters Ropivacaine 0.2% administered via injection perioperatively.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1- Patients 18 or older 2 - Patients undergoing primary total knee replacement at the University of Miami Hospital 3 - Patients that have capacity to provide medical consent
Exclusion criteria
1. All patients under the age of 18 2. Prisoners, uncontrolled diabetics, increased risk of bleeding, pregnant women, women planning on becoming pregnant in the next year, and women who think they might be pregnant. 3. Patients with prior surgery or history of infection on the joint of interest. 4. Patients on steroid preoperatively. 5. Inability to provide medical consent. 6. Patients with a history of significant unmitigated pain in parts of their body not including the knee the procedure is to be performed or a history of pain catastrophizing (the tendency to magnify the threat value of the pain stimulus and to feel helpless in the context of pain, and by a relative inability to inhibit pain-related thoughts in anticipation of, during or following a painful event) regarding pain anywhere in the body. 7. Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant. 8. Allergy to local anesthetic or any medication used in the standard protocol for joint replacement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Status as Measured by Numeric Pain Scale | 2 hours postoperatively | Scale with numeric scores ranging from 0 (least) to 10 (most) pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of Nausea | 2 hours postoperatively | Count of the number of episodes of nausea per patient |
| Patients Reporting Vomiting | 2 hours postoperatively | Count of the number of patients reporting vomiting |
| Episodes of Vomiting | 2 hours postoperatively | Count of the number of episodes of vomiting per patient |
| Total Opioid Consumption | 2 hours postoperatively | Measure of the amount of morphine milliequivalents consumed by the patient |
| Patients Reporting Nausea | 2 hours postoperatively | Count of the number of patients reporting nausea |
| Hours Hospitalized | Up to 336 hours postoperatively | Number of hours hospitalized |
| Discharges by Midnight POD0 | Up to 24 hours postoperatively | The number of patients discharged home by midnight on postoperative day zero |
| Discharges by Midnight on POD1 | Up to 48 hours postoperatively | The number of patients discharged home by midnight postoperative day one |
| Nights Hospitalized | Up to 14 nights postoperatively | Number of nights hospitalized |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preoperative Adductor Canal Block Group Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
Dexamethasone: Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
Acetaminophen: 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
Lyrica: Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
Celebrex: 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
Meloxicam: 30mg administered via IV once postoperatively within 24 hours for pain and swelling
Oxycodone: 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
Ropivacaine: 20 milliliters Ropivacaine 0.2% administered via injection perioperatively. | 46 |
| Postoperative Adductor Canal Block Group Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours
Dexamethasone: Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
Acetaminophen: 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
Lyrica: Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
Celebrex: 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
Meloxicam: 30mg administered via IV once postoperatively within 24 hours for pain and swelling
Oxycodone: 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
Ropivacaine: 20 milliliters Ropivacaine 0.2% administered via injection perioperatively. | 38 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Preoperative Adductor Canal Block Group | Postoperative Adductor Canal Block Group | Total |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 9.12 | 65 years STANDARD_DEVIATION 9.75 | 65 years STANDARD_DEVIATION 9.38 |
| Body Mass Index (BMI) | 30.50 kg/m^2 STANDARD_DEVIATION 4.73 | 30.90 kg/m^2 STANDARD_DEVIATION 4.18 | 30.80 kg/m^2 STANDARD_DEVIATION 4.51 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 31 Participants | 26 Participants | 57 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 38 |
| other Total, other adverse events | 0 / 46 | 0 / 38 |
| serious Total, serious adverse events | 0 / 46 | 0 / 38 |
Outcome results
Primary
Pain Status as Measured by Numeric Pain Scale
Scale with numeric scores ranging from 0 (least) to 10 (most) pain
Time frame: 2 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Pain Status as Measured by Numeric Pain Scale | 2 score on a scale |
| Postoperative Adductor Canal Block Group | Pain Status as Measured by Numeric Pain Scale | 4.00 score on a scale |
Primary
Pain Status as Measured by Numeric Pain Scale
Scale with numeric scores ranging from 0 (least) to 10 (most) pain
Time frame: 24 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Pain Status as Measured by Numeric Pain Scale | 6.00 score on a scale |
| Postoperative Adductor Canal Block Group | Pain Status as Measured by Numeric Pain Scale | 6.00 score on a scale |
Secondary
Discharges by Midnight on POD1
The number of patients discharged home by midnight postoperative day one
Time frame: Up to 48 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Discharges by Midnight on POD1 | 40 Participants |
| Postoperative Adductor Canal Block Group | Discharges by Midnight on POD1 | 29 Participants |
Secondary
Discharges by Midnight POD0
The number of patients discharged home by midnight on postoperative day zero
Time frame: Up to 24 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Discharges by Midnight POD0 | 3 Participants |
| Postoperative Adductor Canal Block Group | Discharges by Midnight POD0 | 4 Participants |
Secondary
Episodes of Nausea
Count of the number of episodes of nausea per patient
Time frame: 2 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Episodes of Nausea | 0.00 number of episodes per patient |
| Postoperative Adductor Canal Block Group | Episodes of Nausea | 0.00 number of episodes per patient |
Secondary
Episodes of Nausea
Count of the number of episodes of nausea per patient
Time frame: 24 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Episodes of Nausea | 0.00 number of episodes per patient |
| Postoperative Adductor Canal Block Group | Episodes of Nausea | 0.00 number of episodes per patient |
Secondary
Episodes of Vomiting
Count of the number of episodes of vomiting per patient
Time frame: 24 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Episodes of Vomiting | 0.00 number of episodes per patient |
| Postoperative Adductor Canal Block Group | Episodes of Vomiting | 0.00 number of episodes per patient |
Secondary
Episodes of Vomiting
Count of the number of episodes of vomiting per patient
Time frame: 2 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Episodes of Vomiting | 0.00 number of episodes per patient |
| Postoperative Adductor Canal Block Group | Episodes of Vomiting | 0.00 number of episodes per patient |
Secondary
Hours Hospitalized
Number of hours hospitalized
Time frame: Up to 336 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Hours Hospitalized | 23.66 hours |
| Postoperative Adductor Canal Block Group | Hours Hospitalized | 25.92 hours |
Secondary
Nights Hospitalized
Number of nights hospitalized
Time frame: Up to 14 nights postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Nights Hospitalized | 1.00 nights |
| Postoperative Adductor Canal Block Group | Nights Hospitalized | 1.00 nights |
Secondary
Patients Reporting Nausea
Count of the number of patients reporting nausea
Time frame: 2 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Patients Reporting Nausea | 7 Participants |
| Postoperative Adductor Canal Block Group | Patients Reporting Nausea | 4 Participants |
Secondary
Patients Reporting Nausea
Count of the number of patients reporting nausea
Time frame: 24 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Patients Reporting Nausea | 8 Participants |
| Postoperative Adductor Canal Block Group | Patients Reporting Nausea | 5 Participants |
Secondary
Patients Reporting Vomiting
Count of the number of patients reporting vomiting
Time frame: 2 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Patients Reporting Vomiting | 1 Participants |
| Postoperative Adductor Canal Block Group | Patients Reporting Vomiting | 1 Participants |
Secondary
Patients Reporting Vomiting
Count of the number of patients reporting vomiting
Time frame: 24 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Patients Reporting Vomiting | 3 Participants |
| Postoperative Adductor Canal Block Group | Patients Reporting Vomiting | 2 Participants |
Secondary
Total Opioid Consumption
Measure of the amount of morphine milliequivalents consumed by the patient
Time frame: 2 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Total Opioid Consumption | 19.50 milligram morphine equivalents |
| Postoperative Adductor Canal Block Group | Total Opioid Consumption | 30.00 milligram morphine equivalents |
Secondary
Total Opioid Consumption
Measure of the amount of morphine milliequivalents consumed by the patient
Time frame: 24 hours postoperatively
Population: Patients who completed the study in one of the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Adductor Canal Block Group | Total Opioid Consumption | 45.00 milligram morphine equivalents |
| Postoperative Adductor Canal Block Group | Total Opioid Consumption | 36.00 milligram morphine equivalents |