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

Phase 4

Completed

• Conditions: Postoperative Pain; Knee Arthroplasty
• Interventions: Procedure: Adductor-Canal-Blockade with Ropivacaine; Procedure: Adductor-Canal-blockade with saline

• Registration Number: NCT01261897
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Study Start: 2011-01
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-03
• Last Update Posted: 2011-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adductor-Canal-Blockade with Ropivacaine	Adductor-Canal-Blockade with Ropivacaine	-
Adductor-Canal-blockade with saline	Adductor-Canal-blockade with saline	-

Primary Outcome Measures

Name	Time	Method
Pain during 45 degrees active flexion of the knee	1 hour postoperative	0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative

Secondary Outcome Measures

Name	Time	Method
Pain during 45 degrees active flexion of the knee	0-6 hours postoperative	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.
Pain during rest	1-6 hours postoperative	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.
A change in pain score in the ropivacaine group, after activating the block	30-60 minutes postoperative	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.
Total morphine consumption	30 minutes - 6 hours postoperative	Total morphine consumption at the interval 30 minutes - 6 hours postoperative.
Postoperative nausea	1-6 hours postoperative	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.
Postoperative vomiting	1-6 hours postoperative	Number of vomiting episodes at the interval 1-6 hours postoperative.
Zofran consumption	1-6 hours postoperative	Total zofran consumption at the intervals 1-6 hours postoperative.
Sedation	1-6 hours postoperative	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.

Trial Locations

Locations (1)

Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital; 🇩🇰 Gentofte, Hellerup, Denmark