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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04400708
Other study ID # 2004-253-11
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 28, 2020
Est. completion date June 29, 2021

Study information

Verified date November 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 29, 2021
Est. primary completion date June 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary the sum of pain score 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 2 hours, 6 hours, 12 hours, and 24 hours after intervention
Secondary Postoperative nausea and vomiting 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 hours, 6 hours, 12 hours, and 24 hours after intervention
Secondary Postoperative opioid consumption amount of postoperative opioid consumption based on oral morphine equivalent daily dose 2 hours, 6 hours, 12 hours, and 24 hours intervention
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