Continuous Distal Adductor Canal Block With Periarticular Local Anesthetic Infiltration Versus Continuous Distal Adductor Canal Block Alone for Analgesia After Total Knee Arthroplasty

January 9, 2024 updated by: Yonsei University
Continuous administration of local anesthetics to the distal adductor canal could spread into the popliteal fossa and contribute to analgesic effects on posterior knee pain. Periarticular local anesthetic infiltration is a component of multimodal joint pathways and the posterior knee capsule was among the tissues routinely infiltrated. It is expected that there will be overlapping effects of distal adductor canal block and periarticular injection. Therefore, we aim to compare the postoperative pain in the group that received only continuous distal adductor canal block and the group that received both continuous distal adductor canal block and periarticular injection. Sixty-six patients scheduled for total knee arthroplasty will be randomly divided into the two groups. In group 1, the adductor canal catheter is inserted 2cm above the adductor hiatus. In group 2, the adductor canal catheter is inserted where the nerve block performed in group 1 and periarticular injection are performed intraoperatively.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yong Seon Choi
  • Phone Number: 82-2-2224-3919
  • Email: yschoi@yuhs.ac

Study Locations

      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective unilateral total knee arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study 2. Hepatic or renal insufficiency 3. Opioid dependency 4. Coagulopathy 5. Pre-existing neurologic or anatomic deficits in the lower extremities 6. Severe psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Distal adductor canal block
Participants receiving continuous distal adductor canal block
All catheters were inserted under a full aseptic technique using a real-time ultrasound-guided in-plane approach by an experienced anesthesiologist. The adductor canal catheter is inserted 2cm above the adductor hiatus.
Active Comparator: Distal adductor canal block and Periarticular block
Participants receiving continuous distal adductor canal block and periarticular block
All catheters were inserted under a full aseptic technique using a real-time ultrasound-guided in-plane approach by an experienced anesthesiologist. The adductor canal catheter is inserted 2cm above the adductor hiatus.The periarticular injection solution contained 20mL of 7.5 mg/mL ropivacaine, 30mg of ketorolac, and 0.3mL of 1.0 mg/mL epinephrine. These agents were mixed with normal saline to a combined volume of 50mL. The surgeon injected this mixture into the tensor fascia lata, subcutaneous tissues, abductors, short external rotators muscles, and structures in the capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale pain score
Time Frame: postoperative 1 day morning (08:00-09:00 AM)
Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
postoperative 1 day morning (08:00-09:00 AM)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale pain score
Time Frame: postoperative 6 hours, postoperative 1 day afternoon (4:00-5:00 PM), postoperative 2 day morning (08:00-09:00 AM)
Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
postoperative 6 hours, postoperative 1 day afternoon (4:00-5:00 PM), postoperative 2 day morning (08:00-09:00 AM)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yong Seon Choi, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2022-0508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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