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

The Effect of Postoperative Single-injection Adductor Canal Block for Multimodal Pain Control in Patients Receiving Total Knee Arthroplasty Under Spinal Anesthesia

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

Study Overview

• Status: Recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Procedure: control group; Procedure: adductor canal block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Jin-Tae Kim, MD. PhD.; Phone Number: 82-2-2072-3664; Email: jintae73@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Anticipated): August 29, 2021
• Study Completion (Anticipated): May 26, 2022

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 14, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2004-253-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No