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Completed

NCT Number: NCT02292082

The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)

Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

A total of 106 patients undergoing total knee arthroplasty will be randomized into two groups: one to receive only Periarticular injections and the other periarticular injections AND adductor canal block.

Patients will be asked their numeric pain scores before surgery as baseline and at 24 and 48 hours post-operation. Patients also will be asked questions from painOUT questionnaire at 24 and 48 hours.

Time to reach discharge criteria based on physical therapy assessments will also be measured.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
  • Age 18 to 80 years
  • Planned use of regional anesthesia
  • Ability to follow study protocol
  • English speaking (secondary outcomes include questionnaires validated in English only)

Exclusion criteria

Hepatic or renal insufficiency Patients younger than 18 years old and older than 80 Patients intending to receive general anesthesia Patients planning to go to rehab post operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months) Diabetes Patients on workers compensation or disability

Treatment and study plan

Bupivacaine

Drug

Morphine

Drug

methylprednisolone

Drug

Cefazolin

Drug

normal saline

Drug

midazolam

Drug

Propofol

Drug

Dexamethasone

Drug

8 MHz. Chiba needle, 22 G / 4 inches

Device

Primary outcomes

  1. Time to Meet Physical Therapy Discharge Criteria

    Time frame: First 3 days post-operatively

    Time to reach physical therapy (PT) goals

Secondary outcomes

  1. Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1

    Time frame: 24 hours after operating room discharge

    Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable.

  2. NRS Pain Score With Movement POD2

    Time frame: 48 hours after surgery

    NRS pain with movement as reported by the patient. Rated from 0-10. 0 being no pain, 10 being the worst pain imaginable.

  3. Opioid Consumption Postoperative Day (POD) 1

    Time frame: 0-24 hours postoperatively

    Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents)

  4. Opioid Consumption POD2

    Time frame: 24-48 hours postoperative

    Opioid consumption over hours 24-48 postoperatively. Measured in mg OME (oral morphine equivalents). Higher equates to more opioids consumed.

  5. Hospital Length of Stay

    Time frame: Average of 3 days

    Measured in minutes.

  6. Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively

    Time frame: Participants will be followed for the duration of 2 days post operatively in the hospital

    Measures: least pain in the last 24 hours. Scores are measured from 0-10. 0 being no pain to 10 being the worst pain imaginable.

  7. Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively

    Time frame: 24-48 hours postoperative

    Least pain experienced from 24-48 hours postoperative on a scale from 0-10. 0 being no pain at all to 10 being the worst pain imaginable

  8. Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively

    Time frame: 0-24 hours postoperatively

    Painout most pain experienced 0-24 hours postoperatively, measured from 0-10. 0 being no pain to 10 being the worst pain imaginable

  9. Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively

    Time frame: 24-48 hours postoperative

    Painout most pain experienced 24-48 hours postoperatively measured on a scale from 0-10. Higher scores indicate higher pain levels.

  10. Knee Society Score (KSS) at 6 Weeks Postoperatively

    Time frame: Post operatively at approximately 6 weeks after surgery

    KSS (Knee Society Score) score measured at 6 weeks postoperatively. The scale is from 0-100. Scores below 60 indicate poor function, 60-69 indicate fair, 70-79 indicate good, and 80-100 indicate excellent functional scores. KSS measures knee pain, flexion contracture,extension lag, alignment, stability, and total range of flexion and generates an associated score correlating to knee function. Higher is better. There is no sub score - only the cumulative Knee Society Score.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Acronym: ACB PAI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2014
Registry last updated
Jan 11, 2019

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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