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Single Injection Adductor Canal Block vs Catheter for Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02798835
Recruitment Status : Completed
First Posted : June 14, 2016
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Steven Lee, University of British Columbia

Brief Summary:
This study investigates single injection adductor canal block (ACB) with or without intravenous dexamethasone and adductor canal catheter for pain management of total knee arthroplasty. This is a non-inferiority trial seeking to determine whether single injection ACB with dexamethasone is "no worse" than a continuous catheter.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Drug: Adductor canal block Drug: Adductor canal block with dexamethasone Drug: Adductor canal catheter Drug: Bupivacaine Drug: Fentanyl Drug: Ropivacaine 0.5% Injectable Solution Drug: Dexamethasone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adductor Canal Block: Single Injection vs Catheter for Pain Management of Total Knee Arthroplasty - A Randomized, Unblinded, Non-Inferiority Trial
Actual Study Start Date : July 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Adductor Canal block
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
Drug: Adductor canal block
Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.

Drug: Bupivacaine
Used in spinal anesthetic

Drug: Fentanyl
May or may not be used in spinal anesthetic

Drug: Ropivacaine 0.5% Injectable Solution
Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.

Active Comparator: Adductor canal block with dexamethasone
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
Drug: Adductor canal block with dexamethasone
Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.

Drug: Bupivacaine
Used in spinal anesthetic

Drug: Fentanyl
May or may not be used in spinal anesthetic

Drug: Ropivacaine 0.5% Injectable Solution
Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.

Drug: Dexamethasone
To be given intravenously at time of nerve block to one of the study arms.

Active Comparator: Adductor canal catheter
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
Drug: Adductor canal catheter
Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.

Drug: Bupivacaine
Used in spinal anesthetic

Drug: Fentanyl
May or may not be used in spinal anesthetic

Drug: Ropivacaine 0.5% Injectable Solution
Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.




Primary Outcome Measures :
  1. Cumulative 24 Hour Oral Morphine Equivalent Consumption [ Time Frame: 24 hours (Day 1) ]
    Post-operative analgesia at 24 hours


Secondary Outcome Measures :
  1. Cumulative 12 Hour Oral Morphine Equivalent Consumption [ Time Frame: 12 hours (Day 0) ]
    Post-operative analgesia at 12 hours

  2. Cumulative 48 Hour Oral Morphine Equivalent Consumption [ Time Frame: 48 hours (Day 2) ]
    Post-operative analgesia at 48 hours

  3. Pain Score [ Time Frame: 12, 24 and 48 hours ]
    Patient's level of pain using NRS (Numeric Ratings Scale) pain scale where the range is 0 (no pain) to 10 (worst pain)

  4. Quality of Recovery (QoR-40) [ Time Frame: 48 hours (Day 2) ]
    Quality of recovery measured using the QoR-40 at 48 hours postoperatively. This is a validated scale where a higher score denotes better recovery/satisfaction after surgery. The range is 40-200.

  5. Length of Stay [ Time Frame: From surgical date until hospital discharge, up to 3 weeks ]
    Time to hospital discharge

  6. Incidence of Participants With Nausea/Vomiting Requiring Anti-emetics [ Time Frame: 0 to 48 hours ]
    Number of Participants with Nausea/Vomiting requiring anti-emetics from 0-48 hours after surgery.

  7. Time to First Use of PCA [ Time Frame: 0 to 48 hours ]
    from time zero to first press of PCA button


Other Outcome Measures:
  1. Adductor Canal Block Complications [ Time Frame: From time of catheter insertion until catheter removal, up to Day2/48 hours ]
    Incidence of catheter dislodgement or site infection

  2. Nerve Block Complications [ Time Frame: 0 to 48 hours ]
    Nerve block complications at any time point during study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent
  • Patients with an American Society of Anaesthesiology (ASA) classification 1 to 3
  • Patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30 mg morphine equivalents
  • Patients must be able to understand and be able to use patient controlled analgesia
  • Patients must be undergoing a primary total knee arthroplasty with neuraxial anesthesia

Exclusion Criteria:

  • Patients with a contraindication to neuraxial and/or regional anaesthesia
  • Patients with an allergy to local anaesthetics
  • Patients who have chronic pain not related to their knee joint
  • Patients with chronic opioid use (daily or almost daily use >3 months)
  • Patients with contraindications to dexamethasone (allergy, infection, Insulin dependent Diabetes Mellitus)
  • Patients with pre-existing neuropathy
  • Patients with hepatic failure
  • Patients with renal failure with eGFR<60
  • Patients with allergy to ketorolac or NSAIDs

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): NCT02798835


Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Steven Lee, MD University of British Columbia
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Steven Lee, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02798835    
Other Study ID Numbers: H16-01058
First Posted: June 14, 2016    Key Record Dates
Results First Posted: September 4, 2020
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Fentanyl
Bupivacaine
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General