The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191593
• Other study ID #: SM1-PJ-10
• Secondary ID: 2010-021161-71
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2010
• Last updated: August 21, 2013
• Start date: September 2010
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• 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 pain and morphine consumption after revision knee arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Revision Knee Arthroplasty in general anaesthesia

• American society of anesthesiologists (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

Study Design

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

Related Conditions & MeSH terms

• Knee Arthroplasty
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Adductor-Canal-Blockade with Ropivacaine
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 and Surgery, HOC, Rigshospitalet, Denmark	Copenhagen	København Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during 45 degrees active flexion of the knee	0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.	4 hours postoperative	No
Secondary	Pain during 45 degrees active flexion of the knee	0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.	1-8 hours postoperative	No
Secondary	Pain during 45 degrees active flexion of the knee	0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.	24 hours postoperative	No
Secondary	Pain during rest	0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 4, 6 and 8 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-8 hours postoperative.	1-8 hours postoperative	No
Secondary	Pain during rest	0-100 mm at a visual analogue scale (VAS), at 24 hours postoperative.	24 hours postoperative	No
Secondary	Total morphine consumption	Total morphine consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.	0-24 hours postoperative	No
Secondary	Postoperative nausea	Nausea scores(0-3)registered at 1,2,4,6 and 8 hours postoperative, calculated as mean value for the interval 1-8 hours postoperative.	1-8 hours postoperative	No
Secondary	Postoperative nausea	Nausea score(0-3)at 24 hours postoperative.	24 hours postoperative	No
Secondary	Postoperative vomiting	Number of vomiting episodes at the intervals 0-8, 8-24 and 0-24 hours postoperative.	0-24 hours postoperative	No
Secondary	Zofran consumption	Total zofran consumption at the intervals 0-8, 8-24 and 0-24 hours postoperative.	0-24 hours postoperative	No
Secondary	Sedation	Sedation score (0-3) registered at 1,2,4,6 and 8 hours postoperative, calculated as the mean value for the interval 1-8 hours postoperative.	1-8 hours postoperative	No
Secondary	Sedation	Sedation score (0-3) at 24 hours postoperative.	24 hours postoperative	No