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The purpose of this study is to compare a single shot block, 24 hours, and 48 hour continuous catheter nerve block done via the adductor canal method in adult patients who have under gone total knee arthroplasty. Visual analogue scores, opioid consumption, time to up and go, ambulation, manual muscle tests, and Tinetti scores up to 72 hours post operatively will be used for comparison.
If the patient is willing to participate and signs the consent, he/she will be randomized to one of the three treatment groups:
The choice of anesthetic technique will be at the discretion of the anesthesiologist. In our institution we usually advocate for spinal anesthesia for total knee arthroplasty. All patients will receive their multimodal perioperative pain protocol (MP3) medication as per protocol in the patient receiving area (400 mg of gabapentin, 200 mg of Celecoxib, and 1gm of acetaminophen).
Patients will be monitored during block performance with standard ASA monitors. All patients will be receiving 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation.
Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite S nerve machine will be used with a high frequency linear (HFL) US probe with 6-13 MHZ frequency. Both single shot and continuous adductor canal block will be performed according to the standard operating practices in our department 4. Ultrasound survey at the medial part of the thigh will take place, halfway between the superior anterior iliac spine and the patella. In a short axis view, the femoral artery will be identified underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery. The needle will be introduced in-plane and 2 to 3 mL of local anesthesia bolus will be used to verify correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal.
For single shot blocks: A bolus of total volume of 20 ml of ropivicaine 0.5% will be injected through the needle.
For the continuous block: The catheter will be introduced and advanced 2-3 cm beyond the tip of the needle under ultrasound visualization. The needle was withdrawn over the catheter. Injection of a bolus of 5 ml of ropivacaine 0.5% will take place through the catheter while observing the spread of local anesthetic under ultrasound. The catheter hub will be affixed to the upper lateral thigh with sterile occlusive dressings and an anchoring device.
Block success will be defined as a change in cutaneous sensation to touch with an alcohol pad in the saphenous nerve distribution over the medial leg within 30min after injection. Subjects with successful catheter placement per protocol and nerve block onset were retained in the study. Subjects with a failed catheter insertion or misplaced catheter indicated by a lack of sensory changes had their catheter replaced or were withdrawn from the study.
At the conclusion of surgery, the catheters will be connected to a pump that will infuse local anesthetic. Ropivicaine 0.2% at 8 ml/hour. In the postoperative anesthesia care unit, intermittent boluses of hydromorphone will be used as needed. Postoperative analgesia will follow the MP3 protocol. Drugs that are used for the multimodal analgesia protocol include acetaminophen (1 gm every 8 hours for 72 hours), celecoxib (200 mg every 8 hours for 72 hours), Gabapentin (300 mg every 8 hours for one week if the patient is opioid naïve and for two weeks if patients are opioid tolerant), and oxycodone (5-10-15 mg oral as needed every 4 hours for pain based on patient reported pain score).
All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during surgery. The protocol for prophylaxis against PONV include administration of 4 mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250 mg/dl.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single shot adductor canal block | Active Comparator | adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA |
|
| 24 hour continuous adductor canal block | Active Comparator | adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA |
|
| 48 hour continuous adductor canal block | Active Comparator | adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20ml bolus of 0.5% ropivicaine | Drug | Local anesthetic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Severe Pain at 48 Hours After Surgery | The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores at 48 Hours After Surgery | Average pain scores 48 hours after surgery. The scale used is the numeric rating pain scale. The scale values range from 0-10/ where 0 is no pain and 10 is the worst pain possible imagined on this scale | 48 hours |
| Functional Recovery After Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nabil M Elkassabany, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Shot Adductor Canal Block | adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic |
| FG001 | 24 Hour Continuous Adductor Canal Block | adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic |
| FG002 | 48 Hour Continuous Adductor Canal Block | adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Shot Adductor Canal Block | adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic |
| BG001 | 24 Hour Continuous Adductor Canal Block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients With Severe Pain at 48 Hours After Surgery | The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day | Posted | Number | percentage of patients with severe pain | 48 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Shot Adductor Canal Block | adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA 20ml bolus of 0.5% ropivicaine: Local anesthetic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nabil Elkassabany | University of Pennsylvania | 2156628000 | nabil.elkassabany@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 0.2% Ropivicaine at 8 milliliter/hour |
| Drug |
Local anesthetic |
|
| 5ml bolus of 0.5% ropivicaine | Drug | Local anesthetic |
|
Cumulative ambulation distance in the second postoperative day measured in feet |
| 48 hours |
| Patient-oriented Outcomes | Quality of recovery (QoR)-9 score on the second day after surgery. This score is a result of a 9 item questionnaire. Answers to each item/question is scored as (0-1-2). The wort score a patient get in the questionnaire is 0 and the best score is 18, depending on the answer of each of the 9 questions and the sum of the scores of these answers | 48 hours |
adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic |
| BG002 | 48 Hour Continuous Adductor Canal Block | adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | 48 Hour Continuous Adductor Canal Block | adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic |
|
|
| Secondary | Pain Scores at 48 Hours After Surgery | Average pain scores 48 hours after surgery. The scale used is the numeric rating pain scale. The scale values range from 0-10/ where 0 is no pain and 10 is the worst pain possible imagined on this scale | Posted | Mean | Standard Deviation | units on a scale ( Pain score) | 48 hours |
|
|
|
| Secondary | Functional Recovery After Surgery | Cumulative ambulation distance in the second postoperative day measured in feet | cumulative ambulation distance in second day after surgery | Posted | Median | Inter-Quartile Range | Feet | 48 hours |
|
|
|
| Secondary | Patient-oriented Outcomes | Quality of recovery (QoR)-9 score on the second day after surgery. This score is a result of a 9 item questionnaire. Answers to each item/question is scored as (0-1-2). The wort score a patient get in the questionnaire is 0 and the best score is 18, depending on the answer of each of the 9 questions and the sum of the scores of these answers | Posted | Median | Inter-Quartile Range | units on a scale ( QoR score) | 48 hours |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | 24 Hour Continuous Adductor Canal Block | adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic | 0 | 51 | 0 | 51 |
| EG002 | 48 Hour Continuous Adductor Canal Block | adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA 0.2% Ropivicaine at 8 milliliter/hour: Local anesthetic 5ml bolus of 0.5% ropivicaine: Local anesthetic | 0 | 52 | 0 | 52 |
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