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

NCT04292392 | Withdrawn

• 1 other identifier: 20.0132
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Arthropathy

Outcome Measures

Primary Outcomes (10)

• 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

• 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.]

• 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

• 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

• 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

• 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

Study Arms (3)

A - ACB + Periarticular Block

EXPERIMENTAL

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

B - ACB + IPACK Block

EXPERIMENTAL

Group B: patient will receive a preop ACB+IPACK block before TKA surgery only

Other: preop ACB+IPACK block

C - ACB + IPACK + Periarticular Block

EXPERIMENTAL

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

Interventions

preop ACB, followed by Intra-articular block during TKA surgery OTHER

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

A - ACB + Periarticular Block

preop ACB+IPACK block OTHER

Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block

B - ACB + IPACK Block

preop ACB+IPACK block, followed by Intra-articular block during TKA surgery OTHER

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

C - ACB + IPACK + Periarticular Block

Eligibility Criteria

• Age: 22 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Study Officials

• Arthur L Malkani, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Adult Reconstruction, Dept. of Orthopaedic Surgery

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: April 6, 2020
• Primary Completion: August 15, 2020
• Study Completion: September 30, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)