Clinical trial NCT05980546: Genicular and Anterior Femoral Cutaneous Nerve Blocks for Total Knee Arthroplasty
Official title: A Randomized Controlled Trial of Ultrasound Guided Knee Genicular Nerve Block and Anterior Femoral Cutaneous Nerve Block for Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Total Knee Replacement
Genicular Nerve Block
Opioid Use
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized control trial of two groups, intervention vs. control.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numerical Rating Scale (NRS) pain score
timeFrame: in the post-operative care unit (PACU) up to 24 hours after surgery end
measure: Cumulative opioid consumption
timeFrame: 24 hours after surgery end
Secondary outcomes:
measure: Numerical Rating Scale (NRS) pain score
timeFrame: at post operative day 1 and post operative day 2
measure: Cumulative opioid consumption
timeFrame: at post operative day 1, 2, & 7
measure: Brief Pain Inventory (short form)
timeFrame: in the post-operative care unit (PACU), up to 24 hours after surgery end and at 7 days after the day of surgery
measure: Participant satisfaction with pain treatment
timeFrame: in the post-operative care unit (PACU), up to 24 hours after surgery end and at 7 days after the day of surgery
measure: Readiness for home discharge
timeFrame: from induction end (time zero) to readiness for discharge time, up to 7 days
measure: Bang Blinding Index
timeFrame: at 7 days after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jiabin Liu, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.
citation: Kim DH, Choi SS, Yoon SH, Lee SH, Seo DK, Lee IG, Choi WJ, Shin JW. Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Local Anesthetic Alone or in Combination with Corticosteroid. Pain Physician. 2018 Jan;21(1):41-52.
citation: Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.