NCT01254825

Brief Summary

The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to placebo when it comes to analgetic efficacy after Knee-Arthroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_4

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, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

December 6, 2010

Last Update Submit

September 9, 2012

Conditions

Keywords

Adductor Canal Block (ACB)Diagnostic Knee ArthroscopySaphenous nervePainUltrasound block

Outcome Measures

Primary Outcomes (1)

  • Pain-Score (VAS) - patient standing

    Pain-score messured on a Visual Analog Scale (VAS) 2 hours after adductor canal block. Patient standing. Intervention-group vs. placebo-group.

    2 hours postoperative

Secondary Outcomes (8)

  • Pain-score (VAS), patient at rest

    0,1,2,4,6,8,24 hours postoperative

  • Pain-score (VAS), patient standing

    1,2,4,6,8,24 hours postoperative

  • Pain-score (VAS), after 5 meters of walk

    2,4,6,8,24 hours postoperative

  • Total Opioid-consumption

    0-24 hours postoperative

  • Opioid-consumption, postoperative

    0-2, 2-4, 4-6, 6-8, 8-24 hours postoperative

  • +3 more secondary outcomes

Study Arms (2)

Adductor-Canal-Block, Ropivacain

EXPERIMENTAL

Adductor-Canal-Block, 30 mL Ropivacain 7,5 mg/mL. Single dose. Ultrasound-guided application. 36 patients

Procedure: Adductor-Canal-Block, Ropivacain

Adductor-Canal-Block (ACB) - Saline

PLACEBO COMPARATOR

Adductor-Canal-Block, Placebo (30 mL Saline). Ultrasound-guided application. 36 patients.

Procedure: Adductor Canal Block, Placebo (saline)

Interventions

Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.

Also known as: Naropin (Ropivacain)
Adductor-Canal-Block, Ropivacain

Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.

Adductor-Canal-Block (ACB) - Saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Knee-arthroscopy
  • Written consent
  • ASA I-III
  • BMI 19-35

You may not qualify if:

  • Unable to communicate in Danish
  • Allergic reactions toward drugs used in the trial
  • Pregnancy
  • Abuse of alcohol/drugs
  • Daily opioid intake
  • Infection at injection site
  • Can not be mobilised to 5 meters of walk; pre-surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, Glostrup University Hospital

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

Related Publications (1)

  • Espelund M, Fomsgaard JS, Haraszuk J, Dahl JB, Mathiesen O. The efficacy of adductor canal blockade after minor arthroscopic knee surgery--a randomised controlled trial. Acta Anaesthesiol Scand. 2014 Mar;58(3):273-80. doi: 10.1111/aas.12224. Epub 2013 Nov 8.

MeSH Terms

Conditions

Pain

Interventions

RopivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Malene Espelund, MD

    Glostrup University Hospital, Copenhagen, 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
MD

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 7, 2010

Study Start

November 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations