Pain Levels and Opioid Usage in Three Nerve Block Cohorts in Primary TKA

Comparison of Pain Levels and Opioid Usage in ACB + Periarticular Block vs. ACB + IPACK Block vs. ACB + IPACK + Periarticular Block in Patients Undergoing Primary TKA

The primary objective of this study is to compare effect of combined block of ACB (adductor canal block) with IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block and/or Intra-articular block in immediate postoperative and early postop rehabilitation and pain management in patients undergoing primary TKA. The secondary objective is to review both in-hospital and post-discharge pain levels and narcotic usage of primary TKAs, with a minimum 6-week postoperative follow-up.

Study Overview

• Status: Withdrawn
• Conditions: Knee Arthropathy
• Intervention / Treatment: Other: preop ACB, followed by Intra-articular block during TKA surgery; Other: preop ACB+IPACK block; Other: preop ACB+IPACK block, followed by Intra-articular block during TKA surgery

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is indicated for a primary, unilateral TKA secondary to osteoarthritis.
2. Patient age is 22-89 at time of TKA surgery.
3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document.
4. Patient is able to read and speak English.

Exclusion Criteria:

1. Patient is under the age of 22 or over the age of 89.
2. Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis).
3. Patient is scheduled to undergo a bilateral TKA surgery.
4. Patient is unable to read and speak English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A - ACB + Periarticular Block; Group A: patient will receive a preop ACB, followed by Intra-articular block during TKA surgery	Other: preop ACB, followed by Intra-articular block during TKA surgery; Preoperative ACB (adductor canal block), followed by a local anesthetic injection during surgery, which is comprised of the following agents and amounts: Ropivacaine 5mg/ml (49.25ml); Epinephrine 1mg/ml (0.5ml); Ketorolac 30mg/ml (1ml); Clonidine 0.1mg/ml (0.8ml); Saline 48.45ml
EXPERIMENTAL: B - ACB + IPACK Block; Group B: patient will receive a preop ACB+IPACK block before TKA surgery only	Other: preop ACB+IPACK block; Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block
EXPERIMENTAL: C - ACB + IPACK + Periarticular Block; Group C: patient will receive a preop ACB+IPACK block, followed by Intra-articular block during TKA surgery	Other: preop ACB+IPACK block, followed by Intra-articular block during TKA surgery; Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block, followed by a local anesthetic injection during surgery, which is comprised of the following agents and amounts: Ropivacaine 5mg/ml (49.25ml); Epinephrine 1mg/ml (0.5ml); Ketorolac 30mg/ml (1ml); Clonidine 0.1mg/ml (0.8ml); Saline 48.45ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total length of hospital stay	total length of hospital stay as defined by number of days from date of surgery to date of discharge	outcome measure will be taken at 2 weeks postoperatively
WOMAC score	WOMAC score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome.	outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively
Amount of narcotic medication utilized	Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).	outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Ability to rise from a chair independently	Ability to rise from a chair independently (Yes/No)	outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Active range-of-motion (ROM)	Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)	outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Distance that patient is able to walk	Distance that patient is able to walk, as measured in feet	outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Use of an ambulatory assistive device	Use of an ambulatory assistive device (Yes/No)	outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, 6 weeks (± 2 weeks) postoperatively
Knee Society Score	Knee Society Score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. A higher value represents a better outcome	outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively.]
Visual Analog Scale	The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.	outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Incidence of postop complications	Incidence of any postoperative complication that involves hospital readmission and/or a re-operation of the surgical knee.	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively

Collaborators and Investigators

• Sponsor: University of Louisville

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2020
• Primary Completion (ACTUAL): August 15, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (ACTUAL): March 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 20.0132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No