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Adductor Canal Block in an Enhanced Recovery Program After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03915522
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Reis Drudis, Institut de Recerca Biomèdica de Lleida

Brief Summary:
The purpose of this study is to assess the effectivity of adductor canal block performed the day after total knee arthroplasty surgery in reducing pain and improving walking ambulation ability and muscle strength.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Knee Osteoarthritis Procedure: Single adductor canal block Procedure: Simulated adductor canal block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A simple randomization is made to distribute the included patients in two groups: Standard Group and Intervention Group. A table of random numbers is used, first selecting the starting point and later the movement direction remains constant throughout the whole table. The even numbers are allocated in the standard group and the odd ones in the intervention group.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

All patients included in the study are transferred the day after the total knee arthroplasty surgery to the postoperative resuscitation unit.

A sterile dressing of the lower extremity is performed and after the adductor canal is identified with ultrasound image, a medial leg puncture is done with or without doing the canal adductor block. At the end all patients have a sterile apposite on the puncture site.

All variables and outcomes are collected and registered by people not involved in the realization of the intervention.

Primary Purpose: Treatment
Official Title: Adductor Canal Block in an Enhanced Recovery Program After Total Knee Arthroplasty
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : September 2, 2019
Estimated Study Completion Date : September 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Adductor Canal Block
Patients will receive multi-modal analgesia (oral, intravenous and local infiltration anesthesia) for pain management following total knee arthroplasty and in the first postoperative day a single adductor canal block wiht 20cc of 0.5% Ropivacaine using ultrasound guidance .
Procedure: Single adductor canal block
The operated leg is slightly externally rotated and prepared for a block with 2% chlorhexidine and sterile dressing. The adductor canal is identified using ultrasound image at the mid-thigh level and after a subcutaneous injection of 2 ml of 1% lidocaine a total of 20 ml of 0'5% ropivacaine is injected into the canal using a 22 gauge ultrasound-visible needle. In the end, a sterile apposite is placed at the puncture site

Placebo Comparator: Placebo Comparator
Patients will receive multi-modal analgesia (oral, intravenous and local infiltration anesthesia) for pain management following total knee arthroplasty and in the first postoperative day a sham adductor canal block with 2ml of 1% subcutaneous lidocaine at the level of the adductor canal using ultrasound guidance.
Procedure: Simulated adductor canal block
The operated leg is slightly externally rotated and prepared with 2% chlorhexidine and sterile dressing. The adductor canal is identified using ultrasound image at the mid-thigh level and at this leve a subcutaneous injection of 2 ml of 1% lidocaine . After, a sterile apposite is placed at the puncture site.




Primary Outcome Measures :
  1. Change in postoperative pain score at rest and knee flexion: Numerical Rating Scale [ Time Frame: Registered immediately prior to surgery, first postoperative day immediately prior to procedure, 2 hours postprocedure and every 8 hours the first three days in the orthopedic ward. ]
    Assessed using a Numerical Rating Scale (NRS) from 0 to 10


Secondary Outcome Measures :
  1. Knee extensor muscle strength [ Time Frame: Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention ]
    Measured using a hand-held dynamometer

  2. Adductor muscle strength [ Time Frame: Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention ]
    Measured using a hand-held dynamometer

  3. Ability to walk with ten meter walk test [ Time Frame: First and second postoperative day every 12 hours ]
    Measured with the ten meter walk test (TMWT)

  4. Rate of pain rescue treatments. [ Time Frame: First 72 hours following surgery ]
    Rate of intravenous opioid needed by the patients.

  5. Rate of opioid side effects. [ Time Frame: First 72 hours following surgery ]
    Rate of episodes of dizziness or nausea or vomit after opioid intake.

  6. Length of hospital stay [ Time Frame: From date to operation until the data of discharge home, assessed up to 1 month ]
  7. Rate of adductor canal block complications [ Time Frame: First 72 hours following surgery ]
    Including: local swelling, hematoma, vascular or neurological lesion and falls.

  8. Rate of surgery local complications [ Time Frame: From date to operation until the data of discharge home, assessed up to 1 month ]
    Including, hematoma, wound infection, arthroplasty infection, vascular or neurological lesion.

  9. Rate of medical complications [ Time Frame: From date to operation until the data of discharge home, assessed up to 1 month ]
    Including neurological, cardiological, urological and respiratory.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective unilateral total knee arthroplasty
  • American Society of Anesthesiologist (ASA) class 1-3
  • Adults aged 18-85 years old

Exclusion Criteria:

  • Contraindications of the adductor canal block.
  • Contraindications of the local infiltration analgesia technique.
  • Chronic kidney disease
  • Surgery to be performed under general anesthesia.
  • Opioid treatment > 30 mgr morphine or equivalent for more than 3 months time.
  • Neuropathic ipsilateral pain.
  • Inability to understand study procedures.
  • Not acceptance of the procedure (adductor canal block or local infiltration analgesia).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915522


Contacts
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Contact: Reis Drudis Morell, MD 34630011138 reisdrudis@gmail.com
Contact: Jordi Colomina Morales, MD 34 679513862 jordicolomina82@gmail.com

Locations
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Spain
Hospital Universitary Santa Maria Recruiting
Lleida, Spain, 25198
Contact: Reis Drudis Morell, MD    34 630011138    reisdrudis@gmail.com   
Contact: Jordi Colomina Morales, MD    34 679513862    jordicolomina82@gmail.com   
Sponsors and Collaborators
Institut de Recerca Biomèdica de Lleida

Publications:

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Responsible Party: Reis Drudis, Principal Investigator, Institut de Recerca Biomèdica de Lleida
ClinicalTrials.gov Identifier: NCT03915522     History of Changes
Other Study ID Numbers: CEIC-1806
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Reis Drudis, Institut de Recerca Biomèdica de Lleida:
total kee arthroplasty
adductor canal block
multimodal analgesia

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action