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

Not Applicable

Withdrawn

• Conditions: Knee Arthropathy
• Interventions: 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

• Registration Number: NCT04292392
• Lead Sponsor: University of Louisville

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-03
• Study Start: 2020-04-06
• Primary Completion: 2020-08-15
• Study Completion: 2020-09-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A - ACB + Periarticular Block	preop ACB, followed by Intra-articular block during TKA surgery	Group A: patient will receive a preop ACB, followed by Intra-articular block during TKA surgery
B - ACB + IPACK Block	preop ACB+IPACK block	Group B: patient will receive a preop ACB+IPACK block before TKA surgery only
C - ACB + IPACK + Periarticular Block	preop ACB+IPACK block, followed by Intra-articular block during TKA surgery	Group C: patient will receive a preop ACB+IPACK block, followed by Intra-articular block during TKA surgery

Primary Outcome Measures

Name	Time	Method
Distance that patient is able to walk	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, as measured in feet
Visual Analog Scale	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	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.
WOMAC score	outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively	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.
Ability to rise from a chair independently	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 (Yes/No)
total length of hospital stay	outcome measure will be taken at 2 weeks postoperatively	total length of hospital stay as defined by number of days from date of surgery to date of discharge
Knee Society Score	outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively.]	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
Amount of narcotic medication utilized	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 (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Use of an ambulatory assistive device	outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, 6 weeks (± 2 weeks) postoperatively	Use of an ambulatory assistive device (Yes/No)
Active range-of-motion (ROM)	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 ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Incidence of postop complications	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively	Incidence of any postoperative complication that involves hospital readmission and/or a re-operation of the surgical knee.

Trial Locations

Locations (1)

Jewish Hospital; 🇺🇸 Louisville, Kentucky, United States