The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy

Meniscus Lesion Clinical Trial

Official title:

The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254825
• Other study ID #: SM2-ME-10
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2010
• Last updated: September 9, 2012
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to placebo when it comes to analgetic efficacy after Knee-Arthroscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 years

• Knee-arthroscopy

• Written consent

• ASA I-III

• BMI 19-35

Exclusion Criteria:

• Unable to communicate in Danish

• Allergic reactions toward drugs used in the trial

• Pregnancy

• Abuse of alcohol/drugs

• Daily opioid intake

• Infection at injection site

• Can not be mobilised to 5 meters of walk; pre-surgery

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

• Diagnostic Knee Artroscopy
• Meniscus Lesion
• Minor Knee Surgery
• Pain (Knee)

Intervention

Procedure:
• Adductor-Canal-Block, Ropivacain
Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.
• Adductor Canal Block, Placebo (saline)
Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology, Glostrup University Hospital	Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain-Score (VAS) - patient standing	Pain-score messured on a Visual Analog Scale (VAS) 2 hours after adductor canal block. Patient standing. Intervention-group vs. placebo-group.	2 hours postoperative	No
Secondary	Pain-score (VAS), patient at rest	ACB-group vs. placebo	0,1,2,4,6,8,24 hours postoperative	No
Secondary	Pain-score (VAS), patient standing	ACB-group vs. placebo	1,2,4,6,8,24 hours postoperative	No
Secondary	Pain-score (VAS), after 5 meters of walk	ACB-group vs. placebo	2,4,6,8,24 hours postoperative	No
Secondary	Total Opioid-consumption	ACB-group vs. placebo-group	0-24 hours postoperative	No
Secondary	Opioid-consumption, postoperative	i.v. morfin 0-2 hours postoperative tbl. morfin 2-24 hours postoperative ACB vs. placebo	0-2, 2-4, 4-6, 6-8, 8-24 hours postoperative	No
Secondary	Postoperative Nausea and vomiting	Rating-scale 0-3 ACB-group vs. placebo-group	0-1, 1-2, 2-4, 4-6, 6-8, 8-24 hours postoperative	No
Secondary	Postoperative ondansetron consumption	ACB-group vs. placebo-group	In-hospital	No
Secondary	Sedation	Rating-scale: 0-3 ACB-group vs. placebo-group	0,1,2,4,6,8,24 hours postoperative	No