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Single-injection Adductor Canal Block for Total Knee Arthroplasty Under Spinal Anesthesia

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400708
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Brief Summary:
This study evaluates the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Procedure: adductor canal block Procedure: control group Not Applicable

Detailed Description:
This study aims to evaluate the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia. The effect of the single-injection adductor canal and continuous adductor canal block in patients receiving total knee arthroplasty under general anesthesia has been well established. However, due to the residual effect of spinal anesthesia, the effect of the single-injection adductor canal block needs to be determined. The investigators hypothesize that the single-injection adductor canal block will decrease the total sum of 2h, 6h, 12h, and 24h pain score.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Postoperative Single-injection Adductor Canal Block for Multimodal Pain Control in Patients Receiving Total Knee Arthroplasty Under Spinal Anesthesia
Estimated Study Start Date : May 26, 2020
Estimated Primary Completion Date : August 29, 2020
Estimated Study Completion Date : May 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Sham Comparator: control group
normal saline injection
Procedure: control group
After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of normal saline15ml is given.

Experimental: test group
0.5% ropivacaine injection
Procedure: adductor canal block
After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of 0.5% ropivacaine 15ml is given.




Primary Outcome Measures :
  1. the sum of pain score [ Time Frame: 2 hours, 6 hours, 12 hours, and 24 hours after intervention ]
    VAS pain score (0 to 10) is measured using numeric pain rating scale at 2 hours, 6 hours, 12 hours, and 24 hours 0: no pain, 10: worst pain


Secondary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: 2 hours, 6 hours, 12 hours, and 24 hours after intervention ]
    degree of postoperative nausea and vomiting (0 to 3) 0: no nausea, no vomiting, 1: nausea present, but no vomiting, 2: nausea present, vomiting once, 3: vomiting repeatedly within 30 minutes.

  2. Postoperative opioid consumption [ Time Frame: 2 hours, 6 hours, 12 hours, and 24 hours intervention ]
    amount of postoperative opioid consumption based on oral morphine equivalent daily dose



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult patients receiving total-knee arthroplasty under spinal anesthesia
  • ASA class 1-3

Exclusion Criteria:

  • infection at the needle injection site
  • hard for pain evaluation
  • CRPS patient with lower extremity symptom
  • chronic opioid user
  • those with side effect to local anesthetics
  • those getting revision total-knee arthroplasty or with the previous operation at the same knee area
  • those getting the surgery under general anesthesia due to the failed spinal anesthesia
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Responsible Party: Jin-Tae Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04400708    
Other Study ID Numbers: 2004-253-11
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No