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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Morphine; Drug: Dexamethasone; Drug: Bupivacaine; Drug: Midazolam; Drug: Propofol; Drug: Methylprednisolone; Drug: Normal saline; Drug: Cefazolin; Device: 8 MHz. Chiba needle, 22 G / 4 inches

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Morphine; Drug: Dexamethasone; Drug: Bupivacaine; Drug: Midazolam; Drug: Propofol; Drug: Methylprednisolone; Drug: Normal saline; Drug: Cefazolin
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: Morphine; Drug: Dexamethasone; Drug: Bupivacaine; Drug: Midazolam; Drug: Propofol; Drug: Methylprednisolone; Drug: Normal saline; Drug: Cefazolin; Device: 8 MHz. Chiba needle, 22 G / 4 inches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Meet Physical Therapy Discharge Criteria	Time to reach physical therapy (PT) goals	First 3 days post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1	Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable.	24 hours after operating room discharge
NRS Pain Score With Movement POD2	NRS pain with movement as reported by the patient. Rated from 0-10. 0 being no pain, 10 being the worst pain imaginable.	48 hours after surgery
Opioid Consumption Postoperative Day (POD) 1	Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents)	0-24 hours postoperatively
Opioid Consumption POD2	Opioid consumption over hours 24-48 postoperatively. Measured in mg OME (oral morphine equivalents). Higher equates to more opioids consumed.	24-48 hours postoperative
Hospital Length of Stay	Measured in minutes.	Average of 3 days
Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively	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.	Participants will be followed for the duration of 2 days post operatively in the hospital
Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively	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	24-48 hours postoperative
Patient Outcome Questionnaire (painOUT) Most Pain for 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	0-24 hours postoperatively
Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively	Painout most pain experienced 24-48 hours postoperatively measured on a scale from 0-10. Higher scores indicate higher pain levels.	24-48 hours postoperative
Knee Society Score (KSS) at 6 Weeks Postoperatively	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.	Post operatively at approximately 6 weeks after surgery

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Enrique A Goytizolo, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 17, 2014

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Nerve Block; Knee Replacement, Total
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Anti-Bacterial Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Local; Dexamethasone; Methylprednisolone; Midazolam; Propofol; Bupivacaine; Morphine; Cefazolin
• Other Study ID Numbers: 2014-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided