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Completed

NCT Number: NCT02276495

Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine Medical Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACB Control - 20 ml saline injection for ACB

Other

Adductor Canal Block Control (20 ml saline injection)

ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block

Drug

Adductor Canal Block Study (20 ml 0.5% Ropivacaine)

Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline

Drug

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)

Primary outcomes

  1. Pain Score

    Time frame: within 24 hours postoperative

    The primary outcome variable of interest is the median maximum pain score within 24 hours postoperative. Pain scores were rated on a scale from 0 - 10, with 0 being no discomfort/pain and 10 being worst imaginable pain.

Secondary outcomes

  1. Opioid Use

    Time frame: within 24 hours postoperative

    24 Hour post-surgical opioid use

  2. Ambulation Distance

    Time frame: First 24 hours post-operative

    Total distance ambulated during physical therapy during first 24 hours

Other outcomes

  1. Baseline Anxiety

    Time frame: pre-operative day of surgery

    Self-reported subject anxiety prior to surgery

  2. Baseline Pain Score

    Time frame: Preoperatively day of surgery

    Baseline pain preoperatively

  3. NRS Pain Rating

    Time frame: Preop, PACU, and 4,8, 12, and 24 hours post-operatively.

    A modified pain score similar to VAS but rated from 0-10

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2024
First posted
Oct 28, 2014
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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