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

Osteoarthritis Clinical Trial

— ACB PAI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292082
• Other study ID #: 2014-018
• Status: Completed
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: August 2016

Study information

• Verified date: January 2019
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Bupivacaine

• Morphine

• Methylprednisolone

• Cefazolin

• Normal saline

• Midazolam

• Propofol

• Dexamethasone

Device:
• 8 MHz. Chiba needle, 22 G / 4 inches

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Meet Physical Therapy Discharge Criteria	Time to reach physical therapy (PT) goals	First 3 days post-operatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital Length of Stay	Measured in minutes.	Average of 3 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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