Genicular and Anterior Femoral Cutaneous Nerve Blocks for Total Knee Arthroplasty

Opioid Use Clinical Trial

Official title:

A Randomized Controlled Trial of Ultrasound Guided Knee Genicular Nerve Block and Anterior Femoral Cutaneous Nerve Block for Primary Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980546
• Other study ID #: 2023-0063
• Status: Recruiting
• Phase: Phase 4
• Start date: June 7, 2023
• Est. completion date: May 22, 2026

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: Angela Puglisi
• Phone: 646-714-6849
• Email: puglisia[@]hss.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: May 22, 2026
• Est. primary completion date: May 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Total Knee Replacement

Intervention

Drug:
• Bupivacaine Injection
The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.
• Dexamethasone injection
The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.
• Fentanyl
This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.
• Mepivacaine
This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (3)

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/p — View 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 Physicia — View 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/r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS) pain score	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".	in the post-operative care unit (PACU) up to 24 hours after surgery end
Primary	Cumulative opioid consumption	The cumulative opioid consumption measured in oral morphine equivalent (OME).	24 hours after surgery end
Secondary	Numerical Rating Scale (NRS) pain score	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.	at post operative day 1 and post operative day 2
Secondary	Cumulative opioid consumption	The cumulative opioid consumption measured in oral morphine equivalent (OME).	at post operative day 1, 2, & 7
Secondary	Brief Pain Inventory (short form)	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.	in the post-operative care unit (PACU), up to 24 hours after surgery end and at 7 days after the day of surgery
Secondary	Participant satisfaction with pain treatment	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.	in the post-operative care unit (PACU), up to 24 hours after surgery end and at 7 days after the day of surgery
Secondary	Readiness for home discharge	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.	from induction end (time zero) to readiness for discharge time, up to 7 days
Secondary	Bang Blinding Index	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.	at 7 days after surgery