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

NCT01549704 | Completed Phase 4 DMC

• 1 other identifier: SM1-UG-11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain After Total Knee Arthroplasty

Keywords

Total knee arthroplasty; Adductor canal blockade (ACB); High pain responders; US-guided nerve block

Outcome Measures

Primary Outcomes (1)

• Difference in VAS between ACB and placebo during active 45 degrees knee flexion

  45 minutes

Secondary Outcomes (2)

• Difference in mean VAS between the groups during active knee flexion

  15, 30, 60, 75 and 90 minutes

• Difference in mean VAS between the groups at rest

  15, 30, 60, 75 and 90 minutes

Study Arms (2)

Arm RP

OTHER

first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml

Drug: Ropivacaine; Drug: Saline

Arm PR

OTHER

first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml

Drug: Ropivacaine; Drug: Saline

Interventions

Ropivacaine DRUG

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.

Also known as: Naropin

Arm PR; Arm RP

Saline DRUG

please see intervention description for ropivacaine

Also known as: NaCl, placebo

Arm PR; Arm RP

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to communicate in Danish
• Allergic reactions toward drugs used in the
• Abuse of alcohol/drugs
• Unable to cooperate

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Gentofte Hospital

Copenhagen, 2900, Denmark

Location

Related Publications (1)

• Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.

  PMID: 24401802 DERIVED

MeSH Terms

Interventions

Ropivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ulrik Grevstad, MD

  Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 9, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

DK (1)