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Trial record 22 of 29 for:    "Collagen Disease" | "Dexamethasone acetate"

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

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ClinicalTrials.gov Identifier: NCT02292082
Recruitment Status : Completed
First Posted : November 17, 2014
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Bupivacaine Drug: Morphine Drug: Methylprednisolone Drug: Cefazolin Drug: Normal saline Drug: Midazolam Drug: Propofol Drug: Dexamethasone Device: 8 MHz. Chiba needle, 22 G / 4 inches Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
Study Start Date : November 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Peri-Articular Injections only

Intra-Operatively

  • Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
  • Surgeon will perform the periarticular injections:
  • First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
  • Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
  • Intravenous sedation with midazolam and propofol.
Drug: Bupivacaine
Drug: Morphine
Drug: Methylprednisolone
Drug: Cefazolin
Drug: Normal saline
Drug: Midazolam
Drug: Propofol
Drug: Dexamethasone
Experimental: Peri-Articular Injections and Adductor Canal Block

Intra-Operatively

  • Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
  • Adductor canal block technique:
  • Supine position, after IV sedation
  • Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
  • Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
  • 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
  • Local anesthetic will be delivered periarterial between 12 and 6 o'clock
  • Intravenous sedation with midazolam and propofol.
  • First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
  • Second superficial injection prior to closure. 20 ml 0.25% bupivacaine
Drug: Bupivacaine
Drug: Morphine
Drug: Methylprednisolone
Drug: Cefazolin
Drug: Normal saline
Drug: Midazolam
Drug: Propofol
Drug: Dexamethasone
Device: 8 MHz. Chiba needle, 22 G / 4 inches



Primary Outcome Measures :
  1. Time to Meet Physical Therapy Discharge Criteria [ Time Frame: First 3 days post-operatively ]
    Time to reach physical therapy (PT) goals


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292082


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Enrique A Goytizolo, MD Hospital for Special Surgery, New York
  Study Documents (Full-Text)

Documents provided by Hospital for Special Surgery, New York:
Informed Consent Form  [PDF] March 24, 2017


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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02292082     History of Changes
Other Study ID Numbers: 2014-018
First Posted: November 17, 2014    Key Record Dates
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hospital for Special Surgery, New York:
Nerve Block
Rehabilitation
Knee Replacement, Total

Additional relevant MeSH terms:
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Rheumatic Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Cefazolin
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Midazolam
Morphine
Bupivacaine
Propofol
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal