Total Knee Replacement, Genicular Nerve Block, Opioid Use
Conditions
Brief summary
The goal of this randomized controlled trial is to examine if there is a relationship between the addition of the genicular nerve block and anterior femoral cutaneous nerve block in providing analgesia and the use of oral and intravenous medication in patients undergoing a total knee arthroplasty. The main questions it aims to answer are: 1. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' total opioid consumption in the first 24 hours after total knee arthroplasty (TKA) surgery? 2. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' worst numeric rating scale (NRS) pain score in the post-anesthesia care unit (PACU)? 3. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care result in earlier discharge from the post-anesthesia care unit (PACU)? 4. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' total opioid consumption in the first 7 days after total knee arthroplasty (TKA) surgery? 5. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' numerical rating scale (NRS) pain (both at rest and during movement) in the first 24 and 48 hours after surgery? Participants will be randomly assigned to receive the genicular nerve block and anterior femoral cutaneous nerve block in addition to standard of care (intervention group), or not receive the nerve blocks (control group). Comparing the intervention group to the control group, the researcher's primary outcomes are numerical pain in the post-anesthesia care unit and cumulative opioid consumption during the first 24 hours.
Detailed description
Adductor canal nerve block (ACB), infiltration between the popliteal artery and the posterior knee capsule (IPACK), with or without peri-articular infiltration of local anesthetics (PAI), is the current standard of practice for analgesia coverage after total knee arthroplasty at the Hospital for Special Surgery. However, we frequently see patients with moderate post-operative knee pain, particularly on the anterior, middle, and lateral sides of the knee. There is limited clinical research on if adding a genicular nerve block could offer TKA patients a more complete analgesia. This study will test if the addition of genicular nerve block (including superolateral genicular nerve, superomedial genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius) and anterior femoral cutaneous nerve block could offer TKA patients a more complete analgesia. Participants will be randomly assigned to receive the genicular nerve block and anterior femoral cutaneous nerve block in addition to standard of care (intervention group), or not receive the nerve blocks (control group). The main questions it aims to answer are: 1. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' total opioid consumption in the first 24 hours after total knee arthroplasty (TKA) surgery? 2. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' worst numeric rating scale (NRS) pain score in the post-anesthesia care unit (PACU)? 3. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care result in earlier discharge from the post-anesthesia care unit (PACU)? 4. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' total opioid consumption in the first 7 days after total knee arthroplasty (TKA) surgery? 5. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to our current standard of care reduce patients' numerical rating scale (NRS) pain (both at rest and during movement) in the first 24 and 48 hours after surgery? Participants will be randomly assigned to receive the genicular nerve block and anterior femoral cutaneous nerve block in addition to standard of care (intervention group), or not receive the nerve blocks (control group). Comparing the intervention group to the control group, the researcher's primary outcomes are numerical pain in the post-anesthesia care unit and cumulative opioid consumption during the first 24 hours.
Interventions
DRUGBupivacaine Injection
The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.
The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.
DRUGFentanyl
This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.
DRUGMepivacaine
This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Once an individual enrolls, research staff will give the anesthesiologist (a co-investigator) an opaque envelope. Inside the envelope will be an index card to let them know which group the participant is assigned to (intervention or control). Those who will be blinded as to which group the participant is assigned to are: * Participant * Research personnel (research assistants) Those who will not be blinded as to which group the participant is assigned to are: * Primary Investigator * Co-investigator * Biostatistician
Intervention model description
A randomized control trial of two groups, intervention vs. control.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients age 18-80 * patients undergoing ambulatory unilateral total knee arthroplasty, including 23 hour stay cohort * ASA I-III * BMI \< 35
Exclusion criteria
* history of chronic pain syndromes * chronic opioid use (daily morphine milligram equivalents \> 30 mg for at least 3 months) * contraindication to peripheral nerve blocks * contraindication to neuraxial anesthesia * history of peripheral neuropathy or pre-existing neurological deficits * Psychiatrics or cognitive disorder that prohibit patient from following study protocol * allergy to local anesthetic or study medications * multiligament surgery * history of substance abuse * infection at the site of injection * chronic kidney disease * currently taking anticonvulsants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) pain score | in the post-operative care unit (PACU) up to 24 hours after surgery end | The numeric rating scale (NRS) is a pain screening tool used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable. |
| Cumulative opioid consumption | 24 hours after surgery end | The cumulative opioid consumption measured in oral morphine equivalent (OME). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (short form) | in the post-operative care unit (PACU), up to 24 hours after surgery end and at 7 days after the day of surgery | The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. Measured on a scale from 0 to 10. Scoring: 1 - 4 = Mild Pain 5 - 6 = Moderate Pain 7 - 10 = Severe Pain Although measured at different time points the average score at each time point is reported among all participants. |
| Participant satisfaction with pain treatment | in the post-operative care unit (PACU), up to 24 hours after surgery end and at 7 days after the day of surgery | To assess patients' satisfaction with their pain management. Measured on a scale from 0 to 10, with 0 = strongly dissatisfied and 10 = strongly satisfied. Although measured at different time points the average score at each time point is reported among all participants. |
| Numerical Rating Scale (NRS) pain score | at post operative day 1 and post operative day 2 | The numeric rating scale (NRS) is a pain screening tool used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable. Although measured at different time points the average score at each time point is reported among all participants. |
| Bang Blinding Index | at 7 days after surgery | To assess the success of patient and research staff blinding using the bang blinding index. The Bang Blinding Index is calculated per treatment arm, is a continuous value such that -1 \<= Bang BI \<= 1. If the index is 1, all responses are correct, and complete unblinding is inferred. |
| Readiness for home discharge | from induction end (time zero) to readiness for discharge time, up to 7 days | From time zero, the time when the patient is ready for discharge. Time zero corresponds to the time when anesthesia induction is complete (induction end). A subgroup analysis for this outcome is planned, with 1) a primary analysis of all patients discharged on the day of surgery and 2) a secondary analysis of all patients discharged 23 hours after time zero or whose status was changed to inpatient. |
| Cumulative opioid consumption | at post operative day 1, 2, & 7 | The cumulative opioid consumption measured in oral morphine equivalent (OME). Measured at 3 timepoints - POD 1, 2 and 7 |
Countries
United States
Outcome results
None listed