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CompletedNCT01104883Updated Apr 13, 2011

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

A Phase 4 interventional study of Adductor-Canal-Blockade and Adductor-Canal-blockade with saline in Total Knee Arthroplasty, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 2 sites in Denmark. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-04-13.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.

02

Conditions studied

  • Total Knee Arthroplasty

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Keywords

  • Adductor-Canal-Blockade
  • postoperative pain
  • US-guided nerve block
  • total knee arthroplasty
03

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's planned enrollment of 70 is close to the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Total Knee Arthroplasty in spinal anaesthesia
  • ASA 1-3
  • BMI 18-40
  • Written informed consent

Exclusion criteria

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
  • Unable to complete the Timed Up and Go test preoperatively
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Adductor-Canal-Blockade

    Adductor-Canal-Blockade with ropivacaine

    Procedure: Adductor-Canal-Blockade

  • Placebo comparator
    Adductor-Canal-blockade with saline

    Adductor-Canal-blockade with isotonic saline

    Procedure: Adductor-Canal-blockade with saline

Interventions

  • ProcedureAdductor-Canal-Blockade

    US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml

    Also known as: Naropine, Postoperative pain, US-guided nerve block

  • ProcedureAdductor-Canal-blockade with saline

    US-guided Adductor-Canal-blockade with saline

    Also known as: placebo block

06

What researchers measure

Primary outcomes

  1. Total morphine consumption

    Total morphine consumption at the interval 0-24 hours postoperative.

    Time frame: 0-24 hours postoperative

Secondary outcomes

  1. Total morphine consumption

    Total morphine consumption at the intervals 0-2, 0-4, 0-8 and 0-26 hours postoperative.

    Time frame: 0-26 hours postoperative

  2. Pain during rest

    0-100 mm at a visual analogue scale (VAS), at the intervals 2, 4, 8, 24 and 26 hours postoperative, and the area under the curve for the intervals 2-24 and 24-26 hours postoperative.

    Time frame: 0-26 hours postoperative

  3. Pain during 45 degrees active flexion of the knee

    0-100 mm at a visual analogue scale (VAS), at the intervals 2, 4, 8, 24 and 26 hours postoperative, and the area under the curve for the intervals 2-24 and 24-26 hours postoperative.

    Time frame: 0-26 hours postoperative

  4. A change in pain in the placebo group

    0-100 mm at a visual analogue scale (VAS), at the intervals 24 and 26 hours postoperative.

    Time frame: 24-26 hours postoperative

  5. Postoperative nausea

    Nausea scores(0-3)at 2,4,8,24,26 hours postoperative.

    Time frame: 0-26 hours postoperative

  6. Zofran consumption

    Total zofran consumption at the intervals 0-24 and 24-26 hours postoperative.

    Time frame: 0-26 hours postoperative

  7. Sedation

    Seadtion score (0-3) at 2,4,8,24,26 hours postoperative.

    Time frame: 0-26 hours postoperative

  8. Mobilisation

    Number of seconds it takes to complete the "Timed Up and Go" test, at 20 and 26 hours postoperative.

    Time frame: 20-26 hours postoperative

  9. Postoperative vomiting

    Number of vomiting episodes at the intervals 0-2,2-4,4-8,8-24,24-26 hours postoperative.

    Time frame: 0-26 hours postoperative

07

Study locations

2 sites
  • Department of Anaesthesia, Privathospitalet Hamlet, Frederiksberg, Denmark
    Copenhagen, Frederiksberg 2000, Denmark
  • Department of Surgery and Anaesthesia, Glostrup Hospital
    Glostrup Municipality, Glostrup 2600, Denmark
08

References and documents

Publications

  • Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4. PubMed 22221014 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01104883
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
First posted
Apr 16, 2010
Start date
Aug 2010
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Apr 13, 2011

Study contacts

Pia Jæger, MD
principal investigator · Copenhagen University Hospital, Rigshospitalet

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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