Clinical trial NCT03840122: ACB + IPACK Block With or Without Local Infiltration in RA-TKA
Official title: Comparing ACB + IPACK Block With or Without Local Infiltration in Patients Undergoing Primary Robotic Arm-Assisted TKA
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Arthropathy
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the outcomes of an Adductor canal block (ACB) + interspace between the popliteal artery and the capsule of the knee (IPACK) block along with a single intraoperative injection of a standard local anesthetic that includes Ropivacaine, Epinephrine, Ketorolac, Clonidine and saline to an ACB + IPACK block without the intraoperative injection of a standard local anesthetic in patients undergoing Robotic Arm-Assisted TKA (RA-TKA).


Eligibility criteria: Inclusion Criteria:

1. Patient is over the age of 21
2. Patient is scheduled to undergo a unilateral, primary TKA, secondary to osteoarthritis
3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents
4. Patient is able to read and speak English.

Exclusion Criteria:

1. Patient is under the age of 21
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: Return to driving
timeFrame: outcome measure will be taken 2 weeks (± 4 days) postoperatively and 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 Malkani, MD
role: PRINCIPAL_INVESTIGATOR
References: