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

January 7, 2013 updated by: Ulrik Grevstad, University Hospital, Gentofte, Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2900
        • Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm RP
first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml
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.

Other Names:
  • Naropin
Drug: Saline
please see intervention description for ropivacaine
Other Names:
  • NaCl, placebo
Other: Arm PR
first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml
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.

Other Names:
  • Naropin
Drug: Saline
please see intervention description for ropivacaine
Other Names:
  • NaCl, placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in VAS between ACB and placebo during active 45 degrees knee flexion
Time Frame: 45 minutes
45 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in mean VAS between the groups during active knee flexion
Time Frame: 15, 30, 60, 75 and 90 minutes
15, 30, 60, 75 and 90 minutes
Difference in mean VAS between the groups at rest
Time Frame: 15, 30, 60, 75 and 90 minutes
15, 30, 60, 75 and 90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Ulrik Grevstad, MD, Gentofte Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM1-UG-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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