- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02730728
Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block After TKA
A Randomized Study of Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block for Postoperative Analgesia After Total Knee Arthroplasty
Studie Overzicht
Toestand
Gedetailleerde beschrijving
If the patient is willing to participate and signs the consent, he/she will be randomized to one of the three treatment groups:
- Single shot block
- 24 hour catheter
- 48 hour catheter
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 The needle was withdrawn over the catheter.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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients scheduled for primary total knee arthroplasty
- American Society of Anesthesiologists (ASA) physical status I -III
- mentally competent and able to give consent for enrollment in the study
Exclusion Criteria:
- Patient younger than 18 years old
- Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3)
- Revision surgery
- Impaired kidney functions and patient with coagulopathy
- Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 3 months prior to the surgery
- BMI of 40 or more
- Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: 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
|
Plaatselijke verdoving
|
Actieve vergelijker: 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
|
Local anesthetic
Local anesthetic
|
Actieve vergelijker: 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
|
Local anesthetic
Local anesthetic
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Patients With Severe Pain at 48 Hours After Surgery
Tijdsspanne: 48 hours
|
The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day
|
48 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Pain Scores at 48 Hours After Surgery
Tijdsspanne: 48 hours
|
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
Tijdsspanne: 48 hours
|
Cumulative ambulation distance in the second postoperative day measured in feet
|
48 hours
|
Patient-oriented Outcomes
Tijdsspanne: 48 hours
|
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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Nabil M Elkassabany, MD, University of Pennsylvania
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 823219
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Artrose
-
Cartiva, Inc.BeëindigdOSTEOARTHRITISVerenigde Staten
-
Federal University of Rio Grande do SulVoltooid
-
Jiangsu XinChen-Techfields Pharma Co., LTD.VoltooidKNIE OSTEOARTHRITISChina
-
Federal University of São PauloVoltooidKNIE OSTEOARTHRITISBrazilië
-
Tianjin XinChen-Techfields Pharma Co., LTD.VoltooidKNIE OSTEOARTHRITISChina
-
Taiwan Liposome CompanyVoltooidOSTEOARTHRITIS VAN DE KNIETaiwan, Verenigde Staten
Klinische onderzoeken op 20ml bolus van 0,5% ropivicaïne
-
University of PennsylvaniaBeëindigdDistale radiusfractuur | Postoperatieve pijnbestrijdingVerenigde Staten
-
University of PennsylvaniaIngetrokkenPols verwondingen | Postoperatieve pijnbestrijdingVerenigde Staten