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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261897
• Other study ID #: SM2-PJ-10
• Secondary ID: 2010-021918-30
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2010
• Last updated: October 3, 2011
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• 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 objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Total Knee Arthroplasty in general 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

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

• 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-Surgery-Intensive Care, Gentofte Hospital	Gentofte	Hellerup

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 1 hour postoperative	1 hour 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, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.	0-6 hours postoperative	No
Secondary	Pain during rest	0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative.	1-6 hours postoperative	No
Secondary	A change in pain score in the ropivacaine group, after activating the block	0-100 mm at a visual analogue scale (VAS), at 30 and 60 minutes postoperative. A change in pain score in the ropivacaine group compared to the placebo group, after activating the block.	30-60 minutes postoperative	No
Secondary	Total morphine consumption	Total morphine consumption at the interval 30 minutes - 6 hours postoperative.	30 minutes - 6 hours postoperative	No
Secondary	Postoperative nausea	Nausea scores(0-3)registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as mean value for the interval 1-6 hours postoperative.	1-6 hours postoperative	No
Secondary	Postoperative vomiting	Number of vomiting episodes at the interval 1-6 hours postoperative.	1-6 hours postoperative	No
Secondary	Zofran consumption	Total zofran consumption at the intervals 1-6 hours postoperative.	1-6 hours postoperative	No
Secondary	Sedation	Sedation score (0-3) registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the mean value for the interval 1-6 hours postoperative.	1-6 hours postoperative	No