NCT01260363

Brief Summary

Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration analgesia with femoral nerve block after.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2010

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
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 2, 2012

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

December 6, 2010

Last Update Submit

May 1, 2012

Conditions

Injury of Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

  • Numeric Rang Scale pain

    1 day after operation

Secondary Outcomes (1)

  • use of analgetics

    0h, 3h, 24h, 48h

Study Arms (2)

Naropin, Adrenalin, applicationsite

ACTIVE COMPARATOR
Procedure: Local infiltration analgesia

Femoral nerve block

ACTIVE COMPARATOR
Procedure: Femoral nerve block

Interventions

Femoral nerve blockPROCEDURE

Femoral nerve block ultrasound guidet with ropivacaine 20ml 2.5mg/ml

Also known as: FNB
Femoral nerve block
Local infiltration analgesiaPROCEDURE

Local infiltration analgesia with ropivacaine 2.5mg/ml with epfinedrine 5mikrogram/ml. 20ml at harvest site and 20ml at incisionsites.

Also known as: LIA teknik
Naropin, Adrenalin, applicationsite

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing primary anetrior cruciate ligament reconstruction with semiTendinos/gracillis graft
  • Age \> 18 year

You may not qualify if:

  • Revision ACL reconstruction
  • Patients with cartilige lision
  • Patients with arthritis
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Hospital Horsens

Horsens, 8700, Denmark

Location

Related Publications (1)

  • Kristensen PK, Pfeiffer-Jensen M, Storm JO, Thillemann TM. Local infiltration analgesia is comparable to femoral nerve block after anterior cruciate ligament reconstruction with hamstring tendon graft: a randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):317-23. doi: 10.1007/s00167-013-2399-x. Epub 2013 Jan 23.

    PMID: 23338666DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Theis Thillemann, MD, Ph.d.

    Regional hospital Horsens, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 15, 2010

Study Start

November 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 2, 2012

Record last verified: 2012-05

Locations

DK(1)