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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01470391
Other study ID # SM1-PJ-11
Secondary ID
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


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
See also
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Enrolling by invitation NCT05130216 - Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
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Completed NCT01616836 - Optimizing Pain and Rehabilitation After Knee Arthroplasty Phase 3
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Terminated NCT03316118 - US Guided GNB vs Saline Injection for TKA Phase 4
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Enrolling by invitation NCT06188091 - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty N/A