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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:
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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Standard TKA | No Intervention | The standard TKA group will receive the standard of care analgesia. Those in the control group will be given 7 mg of the preservative dexamethasone intravenously. The standard group will be given 2-5 mg of intravenous midazolam and up to 100 mcg fentanyl for sedation and analgesia while the peripheral nerve blocks and spinal anesthesia are being performed. All patients will receive a spinal anesthetic (1.5% mepivacaine 52.5 - 60mg) as well as the standard adductor canal block and infiltration between the popliteal artery and posterior knee capsule block (20 ml of 0.25% bupivacaine with 2 mg preservative free dexamethasone for each block). | |
| Group 2 Genicular TKA | Experimental | The genicular group will receive the study intervention of a genicular nerve block and anterior femoral cutaneous nerve block. The intervention group (genicular nerve block/anterior femoral cutaneous nerve block) will receive additional nerve blocks totaling 30 ml of 0.25% bupivacaine with 4 mg preservative-free dexamethasone (5 ml for each block: SMGN, IMGN, SLGN, NVI; 10ml for AFCN). The genicular group will be given 2-5 mg of intravenous midazolam and up to 100 mcg fentanyl for sedation and analgesia while the peripheral nerve blocks and spinal anesthesia are being performed. All patients will receive a spinal anesthetic (1.5% mepivacaine 52.5 - 60mg) and the standard adductor canal block and infiltration between the popliteal artery and posterior knee capsule block (20 ml of 0.25% bupivacaine with 2 mg preservative free dexamethasone for each block). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Injection | Drug | The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cumulative opioid consumption | The cumulative opioid consumption measured in oral morphine equivalent (OME). | 24 hours after surgery end |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiabin Liu, MD/PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34308957 | Result | 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. | |
| 29357330 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2023 | Aug 7, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D002123 | Calcium Dobesilate |
| D005283 | Fentanyl |
| D008619 | Mepivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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A randomized control trial of two groups, intervention vs. control.
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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:
Those who will not be blinded as to which group the participant is assigned to are:
|
| Dexamethasone injection | Drug | The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections. |
|
|
| Fentanyl | Drug | This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention. |
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| Mepivacaine | Drug | This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention. |
|
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| Cumulative opioid consumption | The cumulative opioid consumption measured in oral morphine equivalent (OME). Measured at 3 timepoints - POD 1, 2 and 7 | at post operative day 1, 2, & 7 |
| 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 |
| 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 |
| 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 |
| 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 |
| 34261807 | Result | 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. |
| D000588 |
| Amines |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |