Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty

Pain After Total Knee Arthroplasty Clinical Trial

Official title:

Effect of Adductor-Canal-Blockade on High Pain Responders the 1. or 2. Postoperative Day After Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549704
• Other study ID #: SM1-UG-11
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2012
• Last updated: January 7, 2013
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDenmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during knee flexion the 1. or 2. day after surgery.

Description:

The patients will be included the 1. or 2. day after surgery. All TKA patients will be screened. Those reporting VAS > 60 during active 45 degrees knee flexion will be asked to participate.

Included patients will receive 2xACB (singleshot) first placebo (30ml saline) and then ropivacaine (30ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• TKA within 48 hours and VAS>60 during active 45 degrees knee flexion despite conventional pain medication.

• Informed consent

• ASA 1-3

• BMI 18-40

Exclusion Criteria:

• Unable to communicate in Danish

• Allergic reactions toward drugs used in the

• Abuse of alcohol/drugs

• Unable to cooperate

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

• Pain After Total Knee Arthroplasty

Intervention

Drug:
• Ropivacaine
Arm RP is receiving 30 ml of ropivacaine 7,5 mg/ml at first blockade (ACB) and after 45 minutes another blockade (ACB) with placebo (saline 30 ml). Arm PR is receiving 30 ml of placebo (saline) at first blockade (ACB) and after 45 minutes another blockade (ACB)with ropivacaine.
• Saline
please see intervention description for ropivacaine

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in VAS between ACB and placebo during active 45 degrees knee flexion		45 minutes	No
Secondary	Difference in mean VAS between the groups during active knee flexion		15, 30, 60, 75 and 90 minutes	No
Secondary	Difference in mean VAS between the groups at rest		15, 30, 60, 75 and 90 minutes	No