Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228759
• Other study ID #: 105097
• Status: Completed
• Phase: N/A
• First received: August 18, 2014
• Last updated: March 7, 2017
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Adductor canal block
All patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block

Locations

Country	Name	City	State
Canada	University hospital, London Health Sciences centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria		24 hours
Secondary	first 24 hour pain scores		24 hours
Secondary	first 96 hour pain scores		96 hours
Secondary	Rescue analgesic frequency		24 hours
Secondary	total analgesic usage in the first 24 and 96 postoperative hours		96 hours