Clinical trial NCT02228759: Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Ambulatory home regional
adductor canal block
Postoperative pain
total knee arthroplasty
Home regional
Fast track arthroplasty
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks with continuous adductor canal block along with multimodal analgesia started pre-operatively and continued into the postoperative period. The study will evaluate the feasibility of home discharge within the first 24 hours following total knee arthroplasty. We will also evaluate the pain scores in the first 5 days following the surgery, causes of delayed discharge and any adverse events.


Eligibility criteria: Inclusion Criteria:

1. Male and females of 40-70years of age
2. Scheduled to undergo unilateral primary total knee arthroplasty
3. ASA Class I, II

Exclusion Criteria:

1. ASA 3, 4
2. Revision surgery
3. Narcotic dependent (opioid intake morphine equivalent \> 10 mg/ day for more than 3 months)
4. Other sources of chronic pain like fibromyalgia
5. Patients with associated significant cardiac, CNS or respiratory disease (poor cardio-respiratory reserve)
6. Major conduction defects in EKG (bifascilular block, CHB); significant valvular heart disease
7. Recent MI/ Stroke/ CHF (in the past 3 months)
8. BMI\> 35
9. Obstructive sleep apnea (AHI \> 15)
10. Patients with coexisting hematological disorder or with deranged coagulation parameters.
11. Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
12. Psychiatric illnesses
13. Uncontrolled diabetes mellitus
14. Lack of informed consent.
15. Allergy to any of the drugs used in the study
16. Preoperative neurological deficits
17. Use of walking aids preoperatively
18. Living alone (Lack of Chaperone/home help)
19. Language barrier
20. Contralateral leg weakness
21. Pregnancy

Primary outcomes:
measure: percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria
timeFrame: 24 hours
Secondary outcomes:
measure: first 24 hour pain scores
timeFrame: 24 hours
measure: first 96 hour pain scores
timeFrame: 96 hours
measure: Rescue analgesic frequency
timeFrame: 24 hours
measure: total analgesic usage in the first 24 and 96 postoperative hours
timeFrame: 96 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: University hospital, London Health Sciences centre
state: Ontario
Study officials:
References:
citation: Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.