The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104883
• Other study ID #: SM1-PJ-2009
• Secondary ID: 2009-017794-37
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2010
• Last updated: April 12, 2011
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2010
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Total Knee Arthroplasty in spinal anaesthesia

• ASA 1-3

• BMI 18-40

• Written informed consent

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

• Unable to complete the Timed Up and Go test preoperatively

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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 7,5 mg/ml
• Adductor-Canal-blockade with saline
US-guided Adductor-Canal-blockade with saline

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia, Privathospitalet Hamlet, Frederiksberg, Denmark	Copenhagen	Frederiksberg
Denmark	Department of Surgery and Anaesthesia, Glostrup Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	Total morphine consumption at the interval 0-24 hours postoperative.	0-24 hours postoperative	No
Secondary	Total morphine consumption	Total morphine consumption at the intervals 0-2, 0-4, 0-8 and 0-26 hours postoperative.	0-26 hours postoperative	No
Secondary	Pain during rest	0-100 mm at a visual analogue scale (VAS), at the intervals 2, 4, 8, 24 and 26 hours postoperative, and the area under the curve for the intervals 2-24 and 24-26 hours postoperative.	0-26 hours postoperative	No
Secondary	Pain during 45 degrees active flexion of the knee	0-100 mm at a visual analogue scale (VAS), at the intervals 2, 4, 8, 24 and 26 hours postoperative, and the area under the curve for the intervals 2-24 and 24-26 hours postoperative.	0-26 hours postoperative	No
Secondary	A change in pain in the placebo group	0-100 mm at a visual analogue scale (VAS), at the intervals 24 and 26 hours postoperative.	24-26 hours postoperative	No
Secondary	Postoperative nausea	Nausea scores(0-3)at 2,4,8,24,26 hours postoperative.	0-26 hours postoperative	No
Secondary	Zofran consumption	Total zofran consumption at the intervals 0-24 and 24-26 hours postoperative.	0-26 hours postoperative	No
Secondary	Sedation	Seadtion score (0-3) at 2,4,8,24,26 hours postoperative.	0-26 hours postoperative	No
Secondary	Mobilisation	Number of seconds it takes to complete the "Timed Up and Go" test, at 20 and 26 hours postoperative.	20-26 hours postoperative	No
Secondary	Postoperative vomiting	Number of vomiting episodes at the intervals 0-2,2-4,4-8,8-24,24-26 hours postoperative.	0-26 hours postoperative	No