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

NCT04400708 | Completed DMC

• 1 other identifier: 2004-253-11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative nausea and vomiting

  2 hours, 6 hours, 12 hours, and 24 hours after intervention

• Postoperative opioid consumption

  2 hours, 6 hours, 12 hours, and 24 hours intervention

Study Arms (2)

control group

SHAM COMPARATOR

normal saline injection

Procedure: control group

test group

EXPERIMENTAL

0.5% ropivacaine injection

Procedure: adductor canal block

Interventions

adductor canal block PROCEDURE

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.

test group

control group PROCEDURE

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.

control group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: May 28, 2020
• Primary Completion: June 22, 2021
• Study Completion: June 29, 2021
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

KR (1)