Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing Total Knee Arthroplasty?

February 22, 2024 updated by: Joseph Brian Rinehart, University of California, Irvine

Does Single Injection Adductor Canal Block Improve Postoperative Analgesia in Patients Receiving Periarticular Local Anesthesia Injections for Total Knee Arthroplasty?

The purpose of the study is to determine the effect of a single injection adductor canal block (ACB) on pain scores within 24 hours post total knee arthroplasty (TKA).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty (TKA), also known as total knee replacement, has been associated with a significant pain burden in the postoperative period. Methods to manage pain associated with this operation have in the past included injecting pain medication into the epidural space of the spinal cord, around a peripheral nerve, around the space surrounding the joint, or a combination of pain management techniques.

In recent years, the femoral nerve block (injection of pain medication around the peripheral nerve, specifically the femoral nerve) has been proposed as an effective way to manage pain while sparing many of the undesirable side effects of narcotic pain medications. Traditional techniques of the femoral nerve block involve the injection of pain medication around the peripheral nerve at the level of the groin area. A nerve block at this point in the path of the femoral nerve affects all of the musculature of the front part of the thigh as well as the nerves responsible for sensation to the majority of the knee joint. The femoral nerve block performed at the level of the groin provides an excellent level of pain relief at the knee joint, but is also associated with weakness of the quadriceps muscle. The resultant quadriceps weakness can both slow the physical therapy process and be a risk factor for post-operative falls. Participation in physical therapy is a critical component of the rehabilitation process and is started as soon as tolerated by the patient. The ideal pain management technique would provide the same degree of pain relief as the femoral nerve block while preserving the strength in the front part of the thigh muscles.

One suggested technique to achieve both of these goals is the injection of a large volume dilute local pain medication mixture around the joint during surgery. This has been used as a substitute to provide pain relief around the joint while maintaining strength in the quadriceps muscle and the ability to participate in physical therapy. This technique however, does not last long since the medication disperses away from the joint space.

A variation of the femoral nerve block in the lower thigh, within a space called the adductor canal, has been demonstrated to provide equivalent amounts of pain relief as a proximal femoral nerve block along with preservation of motor function to the quadriceps muscle. What is not as well-established is whether the combination of injecting pain medication directly around the joint space in the knee along with a single injection of pain medication in the adductor canal in the lower thigh can improve pain scores and extend the duration of pain relief provided compared to only an injection around the joint space.

Study Type

Interventional

Enrollment (Actual)

55

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 Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males and Females age 18+ years old having total knee arthroplasty (TKA) at UCI Medical Center
  • American Society of Anesthesiologists physical status I to III

Exclusion Criteria:

  • Allergy to local anesthetics
  • Pregnancy
  • Nursing Mothers
  • Children <18 years of age
  • Renal impairment (GFR<60 mL/min/1.73m2)
  • Hepatic Impairment (active hepatitis, elevated AST or ALT, jaundice)
  • Opioid tolerant patients (defined as greater than 30 mg Morphine equivalent consumed daily)
  • Patients that are diabetic with peripheral neuropathy
  • BMI greater than 40

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: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACB Control + Local Infiltration
ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline
Other: ACB Control - 20 ml saline injection for ACB
Adductor Canal Block Control (20 ml saline injection)
Drug: Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline

100 mLs of a solution containing:

Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)
Experimental: ACB Study + Local infiltration
ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline
Drug: Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline

100 mLs of a solution containing:

Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)

Drug: ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block
Adductor Canal Block Study (20 ml 0.5% Ropivacaine)
Experimental: ACB Study Only
ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block
Drug: ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block
Adductor Canal Block Study (20 ml 0.5% Ropivacaine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: within 24 hours postoperative
The primary outcome variable of interest is the average maximum pain score within 24 hours postoperative.
within 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Use
Time Frame: within 24 hours postoperative
24 Hour post-surgical opioid use
within 24 hours postoperative
PACU Opioid Use
Time Frame: Postoperative (while in PACU), an expected average of 60 minutes
PACU opioid use
Postoperative (while in PACU), an expected average of 60 minutes
Daily Opioid Use
Time Frame: duration of hospital stay, an expected average of 3 days
Average daily opioid use during hospitalization
duration of hospital stay, an expected average of 3 days
Average NRS Pain Score
Time Frame: within 24 hours postoperative
Average NRS pain score
within 24 hours postoperative
Length of Stay
Time Frame: duration of hospital stay, an expected average of 3 days
Length of hospital stay
duration of hospital stay, an expected average of 3 days

Collaborators and Investigators

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

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Joseph Rinehart, MD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 26, 2014

Primary Completion (Actual)

June 20, 2020

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimated)

October 28, 2014

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20141217
  • UCIANES06 (Other Identifier: UCIANE)

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.

Clinical Trials on Pain Management

Clinical Trials on ACB Control - 20 ml saline injection for ACB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe