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Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block After TKA

5 ottobre 2018 aggiornato da: University of Pennsylvania

A Randomized Study of Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block for Postoperative Analgesia After Total Knee Arthroplasty

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.

Panoramica dello studio

Descrizione dettagliata

If the patient is willing to participate and signs the consent, he/she will be randomized to one of the three treatment groups:

  1. Single shot block
  2. 24 hour catheter
  3. 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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

159

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • University of Pennsylvania

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Anestetico locale
Comparatore attivo: 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
Comparatore attivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patients With Severe Pain at 48 Hours After Surgery
Lasso di tempo: 48 hours
The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day
48 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Scores at 48 Hours After Surgery
Lasso di tempo: 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
Lasso di tempo: 48 hours
Cumulative ambulation distance in the second postoperative day measured in feet
48 hours
Patient-oriented Outcomes
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Nabil M Elkassabany, MD, University of Pennsylvania

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2015

Completamento primario (Effettivo)

30 giugno 2016

Completamento dello studio (Effettivo)

1 gennaio 2017

Date di iscrizione allo studio

Primo inviato

23 marzo 2016

Primo inviato che soddisfa i criteri di controllo qualità

31 marzo 2016

Primo Inserito (Stima)

6 aprile 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 ottobre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 ottobre 2018

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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