Complications; Arthroplasty, Knee Injuries
Conditions
Brief summary
Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.
Detailed description
The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.
Interventions
DRUGBupivacaine
10 ml of 0.25% bupivacaine
10 ml of preservative free normal saline
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia
Exclusion criteria
* Patient refusal * American Society of Anesthesiologists physical status classification of 4 or higher * Pre-existing neuropathy in the femoral or sciatic distribution * Coagulopathy * Infection at the site * Chronic opioid use (greater than 3 months) * Pregnancy * Medical conditions limiting physical therapy participation * Any other contra-indication to regional anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption (mg morEq) | 36 hours | Opioid consumption (morphine equivalents) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Pain Score | Pain burden at 36hr | Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery. |
| Length of Hospitalization | 0 to 192 hours | The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Group Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine | 20 |
| Control Group Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Active Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 9 Participants | 17 Participants |
| Age, Continuous | 68 years | 67 years | 67 years |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Opioid Consumption (mg morEq)
Opioid consumption (morphine equivalents)
Time frame: 36 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | Opioid Consumption (mg morEq) | 48 Morphine Equivalents |
| Control Group | Opioid Consumption (mg morEq) | 60 Morphine Equivalents |
Secondary
Length of Hospitalization
The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.
Time frame: 0 to 192 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Group | Length of Hospitalization | 73 hours |
| Control Group | Length of Hospitalization | 92 hours |
Secondary
Visual Analog Scale Pain Score
Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.
Time frame: Pain burden at 36hr
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Group | Visual Analog Scale Pain Score | 71 scores*hours |
| Control Group | Visual Analog Scale Pain Score | 131 scores*hours |