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Completed

NCT Number: NCT05980546

Genicular and Anterior Femoral Cutaneous Nerve Blocks for Total Knee Arthroplasty

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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:

  • 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?
  • 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)?
  • 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)?
  • 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?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine Injection

Drug

The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.

Other names: Marcaine

Dexamethasone Injection

Drug

The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.

Other names: Ozurdex

Fentanyl

Drug

This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.

Other names: Actiq

Mepivacaine

Drug

This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.

Other names: Carbocaine

Primary outcomes

  1. Numerical Rating Scale (NRS) pain score

    Time frame: 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".

  2. Cumulative opioid consumption

    Time frame: 24 hours after surgery end

    The cumulative opioid consumption measured in oral morphine equivalent (OME).

Secondary outcomes

  1. Numerical Rating Scale (NRS) pain score

    Time frame: 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.

  2. Cumulative opioid consumption

    Time frame: 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

  3. Brief Pain Inventory (short form)

    Time frame: 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.

  4. Participant satisfaction with pain treatment

    Time frame: 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.

  5. Readiness for home discharge

    Time frame: 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.

  6. Bang Blinding Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2023
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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