Clinical trial NCT04292392: Pain Levels and Opioid Usage in Three Nerve Block Cohorts in Primary TKA
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Arthropathy
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: total length of hospital stay
timeFrame: outcome measure will be taken at 2 weeks postoperatively
measure: Knee Society Score
timeFrame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively.]
measure: WOMAC score
timeFrame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively
measure: Visual Analog Scale
timeFrame: 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
measure: Amount of narcotic medication utilized
timeFrame: 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
measure: Ability to rise from a chair independently
timeFrame: 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
measure: Active range-of-motion (ROM)
timeFrame: 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
measure: Distance that patient is able to walk
timeFrame: 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
measure: Use of an ambulatory assistive device
timeFrame: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, 6 weeks (± 2 weeks) postoperatively
measure: Incidence of postop complications
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Arthur L Malkani, MD
role: PRINCIPAL_INVESTIGATOR
References: