NCT01191593

Brief Summary

The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing pain and morphine consumption after revision knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

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

August 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

Enrollment Period

2.6 years

First QC Date

August 30, 2010

Last Update Submit

August 21, 2013

Conditions

Postoperative PainKnee Arthroplasty

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Pain during 45 degrees active flexion of the knee

    0-100 mm at a visual analogue scale (VAS), at 4 hours postoperative.

    4 hours postoperative

Secondary Outcomes (11)

  • Pain during 45 degrees active flexion of the knee

    1-8 hours postoperative

  • Pain during 45 degrees active flexion of the knee

    24 hours postoperative

  • Pain during rest

    1-8 hours postoperative

  • Pain during rest

    24 hours postoperative

  • Total morphine consumption

    0-24 hours postoperative

  • +6 more secondary outcomes

Study Arms (2)

Adductor-Canal-Blockade with ropivacaine

EXPERIMENTAL
Procedure: Adductor-Canal-Blockade with Ropivacaine

Adductor-Canal-blockade with saline

PLACEBO COMPARATOR
Procedure: Adductor-Canal-blockade with saline

Interventions

Adductor-Canal-Blockade with RopivacainePROCEDURE

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

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

US-guided Adductor-Canal-blockade with saline

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

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Revision Knee Arthroplasty in general anaesthesia
  • American society of anesthesiologists (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia and Surgery, HOC, Rigshospitalet, Denmark

Copenhagen, København Ø, 2100, Denmark

Location

Related Publications (1)

  • Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.

    PMID: 25386752DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric 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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 30, 2010

First Posted

August 31, 2010

Study Start

September 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations

DK(1)