Knee Osteoarthritis, Knee Rheumatism
Conditions
Keywords
adductor canal regional block, obturator nerve regional block, total knee arthroplasty, knee replacement surgery, Knee rheumatoid arthritis
Brief summary
One common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. The aim of this study is to determine whether the addition of another regional block called obturator nerve block, which involves injecting numbing medication in the upper thigh region, will improve pain control after surgery while not sacrificing mobility after surgery.
Detailed description
There is currently no consensus on the optimal strategy that provides the most effective postoperative analgesia while preserving ambulation and limiting side effects such as nausea and vomiting. The clinical team's hypothesis is that the obturator nerve block in addition to adductor canal block can target both the anterior and posterior distribution of nerves to the knee to provide superior analgesia while not limiting ambulation. To test this hypothesis, the clinical team will compare the rate of IV opioid consumption in patients who receive a combination of adductor canal block and obturator nerve block at the surgical site versus patients who receive adductor canal block alone.
Interventions
DRUGObturator nerve regional block
Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.
DRUGAdductor canal regional block
Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.
DRUGSaline
Saline as placebo comparator
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized controlled trial with two arms: one arm will receive adductor canal block and obturator nerve block with the local anesthetic bupivacaine; second arm will receive adductor canal block with bupivacaine and obturator nerve block with saline.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo total knee arthroplasty * Planned use of regional anesthesia for procedure * Willing and able to provide informed consent
Exclusion criteria
* Patients on immunosuppressive therapy * Patients with history of diabetes * Patients with lower limb neuropathy * Patients with history of chronic opioid use for \> 3 months, including but not limited to, fentanyl, morphine, oxycodone, methadone * Patients with known allergy or intolerance to any drug used in the study * Patients with history of alcohol or drug abuse * Patients with history of intolerance of nonsteroidal anti-inflammatory drugs * Patients with hepatic or renal insufficiency * ASA score of 4 or greater
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalence Consumption | up to 24 hours after surgery | Total amount of opioids consumed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 1, 6, 12, and 24 hours after surgery | Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced |
| Number of Participants With Nausea or Vomiting | up to 24 hours after surgery | Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited |
| Time to Ambulation | on postoperative day 1 after surgery | The length of time that it takes before the patient is first able to walk with assistance after surgery as assessed by a physical therapist. |
| Time to Breakthrough Pain Medication | up to post operative day 2 after surgery | Time before pain medication needed for breakthrough pain |
| Analgesia Satisfaction Score | 2 weeks after surgery | Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction. |
Countries
United States
Participant flow
Recruitment details
Recruitment began in October with enrollment from December 2017 through December 2018.
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Arm Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine | 30 |
| Saline Control Arm Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Bupivacaine Arm | Saline Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 7.5 | 66.7 years STANDARD_DEVIATION 7.3 | 67.3 years STANDARD_DEVIATION 7.4 |
| Body Mass Index (BMI) | 30.72 kg/m^2 STANDARD_DEVIATION 4.85 | 28.65 kg/m^2 STANDARD_DEVIATION 5.05 | 29.68 kg/m^2 STANDARD_DEVIATION 5.02 |
| 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 | 4 Participants | 7 Participants | 11 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 | 8 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) White | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Morphine Equivalence Consumption
Total amount of opioids consumed
Time frame: up to 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Arm | Morphine Equivalence Consumption | 12.6 MME | Standard Deviation 6.37 |
| Saline Control Arm | Morphine Equivalence Consumption | 18.85 MME | Standard Deviation 7.74 |
Secondary
Analgesia Satisfaction Score
Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.
Time frame: 2 weeks after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Arm | Analgesia Satisfaction Score | 9.24 score on a scale | Standard Deviation 0.93 |
| Saline Control Arm | Analgesia Satisfaction Score | 8.59 score on a scale | Standard Deviation 2.08 |
Secondary
Number of Participants With Nausea or Vomiting
Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited
Time frame: up to 24 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivacaine Arm | Number of Participants With Nausea or Vomiting | 11 Participants |
| Saline Control Arm | Number of Participants With Nausea or Vomiting | 16 Participants |
Secondary
Pain Score
Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced
Time frame: 1, 6, 12, and 24 hours after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine Arm | Pain Score | 12 hours | 4.10 score on a scale | Standard Deviation 2.92 |
| Bupivacaine Arm | Pain Score | 1 hour | 0.17 score on a scale | Standard Deviation 0.64 |
| Bupivacaine Arm | Pain Score | 24 hours | 6.10 score on a scale | Standard Deviation 2.66 |
| Bupivacaine Arm | Pain Score | 6 hours | 2.27 score on a scale | Standard Deviation 2.82 |
| Saline Control Arm | Pain Score | 24 hours | 7.00 score on a scale | Standard Deviation 2.24 |
| Saline Control Arm | Pain Score | 12 hours | 5.13 score on a scale | Standard Deviation 2.22 |
| Saline Control Arm | Pain Score | 6 hours | 2.77 score on a scale | Standard Deviation 2.71 |
| Saline Control Arm | Pain Score | 1 hour | 0.23 score on a scale | Standard Deviation 1.28 |
Secondary
Time to Ambulation
The length of time that it takes before the patient is first able to walk with assistance after surgery as assessed by a physical therapist.
Time frame: on postoperative day 1 after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Arm | Time to Ambulation | 8.98 hours | Standard Deviation 8.13 |
| Saline Control Arm | Time to Ambulation | 7.87 hours | Standard Deviation 8.49 |
Secondary
Time to Breakthrough Pain Medication
Time before pain medication needed for breakthrough pain
Time frame: up to post operative day 2 after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Arm | Time to Breakthrough Pain Medication | 872.54 minutes | Standard Deviation 1044.07 |
| Saline Control Arm | Time to Breakthrough Pain Medication | 510.13 minutes | Standard Deviation 420.69 |