Osteo Arthritis Knee
Conditions
Keywords
femoral nerve block, adductor canal block, analgesia
Brief summary
An observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty.
Detailed description
Subjects undergoing total knee arthroplasty will receive a preoperative adductor canal block with continuous catheter. Following a standardized general anesthetic for the procedure, subjects will be asked to rate their pain using the NRS-11 pain scale in the recovery room. Once the pain is reported at a 5/10 or above, a femoral nerve block will be performed using either 2% chloroprocaine or saline placebo (randomized). Pain scores are then evaluated over the next 30 minutes by a blinded investigator to determine if the femoral block adds any additional analgesic benefit over an adductor canal block.
Interventions
PROCEDUREActive comparator: chloroprocaine
15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
PROCEDURESham comparator: saline
15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Group allocation by sealed envelope; unblinded investigator prepared syringes of study drug (chloroprocaine vs. saline), which look identical to blinded investigator and assessor.
Intervention model description
randomized, blinded observational study
Eligibility
Sex/Gender
ALL
Age
56 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective total knee arthroplasty * ASA Physical Status I-III * BMI 18-40 kg/m2
Exclusion criteria
* Inability to cooperate with protocol * Inability to understand or speak English * Allergy to any local anesthetic * Chronic opioid consumption/abuse (30 or more morphine mg equivalents/day) * Contraindication to adductor canal or femoral nerve block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | Baseline, up to 30 minutes. | Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chloroprocaine 15 ml of 2% chloroprocaine via a femoral nerve block technique
Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. | 8 |
| Saline 15 ml of 0.9% saline via a femoral nerve block technique
Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Chloroprocaine | Total | Saline |
|---|---|---|---|
| Age, Continuous | 68 years | 68 years | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 16 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment United States | 8 participants | 16 participants | 8 participants |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable).
Time frame: Baseline, up to 30 minutes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Chloroprocaine | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 20 minutes post-block | 3.0 units on a scale |
| Chloroprocaine | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 10 minutes post-block | 4.0 units on a scale |
| Chloroprocaine | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | Pre-block | 7.0 units on a scale |
| Chloroprocaine | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 15 minutes post-block | 3.2 units on a scale |
| Chloroprocaine | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 30 minutes post-block | 2.0 units on a scale |
| Chloroprocaine | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 25 minutes post-block | 3.0 units on a scale |
| Chloroprocaine | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 5 minutes post-block | 4.0 units on a scale |
| Saline | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 25 minutes post-block | 5.5 units on a scale |
| Saline | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 30 minutes post-block | 5.5 units on a scale |
| Saline | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | Pre-block | 6.0 units on a scale |
| Saline | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 5 minutes post-block | 6.0 units on a scale |
| Saline | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 10 minutes post-block | 6.5 units on a scale |
| Saline | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 20 minutes post-block | 6.0 units on a scale |
| Saline | Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | 15 minutes post-block | 6.5 units on a scale |