Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength, Pain and Mobilization After Total Knee Replacement

Total Knee Arthroplasty Clinical Trial

Official title:

"A Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength, Pain and Mobilization After Total Knee Arthroplasty: a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470391
• Other study ID #: SM1-PJ-11
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: December 17, 2012
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the Femoral Nerve Block on muscle strength, pain and mobilization after total knee arthroplasty. We hypothesize that the Adductor-Canal-Blockade has the same effect on pain and morphine consumption as the Femoral Nerve Block, but without the same reduction in quadriceps muscle strength.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• ASA 1-3

• BMI > 18 og < 40

• total knee arthroplasty in spinal anesthesia

Exclusion Criteria:

• Can not cooperate to the exam

• Do not speak or understand Danish

• Drug allergy

• Alcohol or drug abuse

• Daily consumption of strong opioids

• Rheumatoid arthritis

• Intake of glucocorticoids

• Effect of spinal anesthesia stopped prior to performing the regional block

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• Adductor-Canal-Blockade
US-guided Adductor-Canal-Blockade with Ropivacaine
• Femoral Nerve Block
US-guided Femoral Nerve Block with Ropivacaine

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia, Copenhagen University Hospital, Frederiksberg	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block		24 h postoperatively	No
Secondary	The difference in adductor muscle strength between the Adductor-Canal-Blockade and the Femoral Nerve Block		24 h postoperatively	No
Secondary	Pain during flexion of the knee	0-100 mm at a visual analogue scale (VAS), calculated as the area under the curve for the interval 2-24 hours postoperatively.	2-24 hours	No
Secondary	Pain at rest	0-100 mm at a visual analogue scale (VAS), calculated as the area under the curve for the interval 2-24 hours postoperatively.	2-24 hours	No
Secondary	Total morphine consumption		0-24 hours	No
Secondary	Postoperative nausea		2-24 hours	No
Secondary	Postoperative vomiting		0-24 hours	No
Secondary	Sedation		2-24 hours	No
Secondary	Zofran consumption	Number of patients recieveing zofran postoperatively	0-24 hours	No
Secondary	The difference in mobilization between the groups		24 hours	No