NCT01470391

Brief Summary

The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the Femoral Nerve Block on muscle strength, pain and mobilization after total knee arthroplasty. We hypothesize that the Adductor-Canal-Blockade has the same effect on pain and morphine consumption as the Femoral Nerve Block, but without the same reduction in quadriceps muscle strength.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

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

Study Start

First participant enrolled

November 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

November 9, 2011

Last Update Submit

December 17, 2012

Conditions

Total Knee Arthroplasty

Keywords

Adductor-Canal-BlockadeFemoral Nerve BlockPostoperative PainTotal Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block

    24 h postoperatively

Secondary Outcomes (9)

  • The difference in adductor muscle strength between the Adductor-Canal-Blockade and the Femoral Nerve Block

    24 h postoperatively

  • Pain during flexion of the knee

    2-24 hours

  • Pain at rest

    2-24 hours

  • Total morphine consumption

    0-24 hours

  • Postoperative nausea

    2-24 hours

  • +4 more secondary outcomes

Study Arms (2)

Adductor-Canal-Blockade

EXPERIMENTAL
Procedure: Adductor-Canal-Blockade

Femoral Nerve Block

ACTIVE COMPARATOR
Procedure: Femoral Nerve Block

Interventions

Adductor-Canal-BlockadePROCEDURE

US-guided Adductor-Canal-Blockade with Ropivacaine

Adductor-Canal-Blockade
Femoral Nerve BlockPROCEDURE

US-guided Femoral Nerve Block with Ropivacaine

Femoral Nerve Block

Eligibility Criteria

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

You may qualify if:

  • ASA 1-3
  • BMI \> 18 og \< 40
  • total knee arthroplasty in spinal anesthesia

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
  • Rheumatoid arthritis
  • Intake of glucocorticoids
  • Effect of spinal anesthesia stopped prior to performing the regional block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia, Copenhagen University Hospital, Frederiksberg

Frederiksberg, Frederiksberg, 2000, Denmark

Location

Related Publications (1)

  • Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.

    PMID: 24121608DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Pia Jæger, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
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
MD

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 11, 2011

Study Start

November 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations

DK(1)