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

Knee Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04292392
• Other study ID #: 20.0132
• Status: Withdrawn
• Phase: N/A
• Start date: April 6, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Intervention

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

Locations

Country	Name	City	State
United States	Jewish Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.]
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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