NCT01104883

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 13, 2011

Status Verified

April 1, 2010

Enrollment Period

7 months

First QC Date

April 12, 2010

Last Update Submit

April 12, 2011

Conditions

Keywords

Adductor-Canal-Blockadepostoperative painUS-guided nerve blocktotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption

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

    0-24 hours postoperative

Secondary Outcomes (9)

  • Total morphine consumption

    0-26 hours postoperative

  • Pain during rest

    0-26 hours postoperative

  • Pain during 45 degrees active flexion of the knee

    0-26 hours postoperative

  • A change in pain in the placebo group

    24-26 hours postoperative

  • Postoperative nausea

    0-26 hours postoperative

  • +4 more secondary outcomes

Study Arms (2)

Adductor-Canal-Blockade

EXPERIMENTAL

Adductor-Canal-Blockade with ropivacaine

Procedure: Adductor-Canal-Blockade

Adductor-Canal-blockade with saline

PLACEBO COMPARATOR

Adductor-Canal-blockade with isotonic saline

Procedure: Adductor-Canal-blockade with saline

Interventions

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

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

US-guided Adductor-Canal-blockade with saline

Also known as: placebo block
Adductor-Canal-blockade with saline

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anaesthesia, Privathospitalet Hamlet, Frederiksberg, Denmark

Copenhagen, Frederiksberg, 2000, Denmark

Location

Department of Surgery and Anaesthesia, Glostrup Hospital

Glostrup Municipality, Glostrup, 2600, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Pia Jæger, MD

    Rigshospitalet, Denmark

    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

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 16, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

April 13, 2011

Record last verified: 2010-04

Locations