NCT00529425

Brief Summary

Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral neck fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2008

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

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 6, 2010

Status Verified

April 1, 2010

First QC Date

September 12, 2007

Last Update Submit

May 5, 2010

Conditions

Femoral Neck Fracture

Keywords

Femoral neck fractureHip fracture

Outcome Measures

Primary Outcomes (1)

  • Consumption of opioids

Secondary Outcomes (1)

  • Pain

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR
Drug: Ropivacaine

Saline

PLACEBO COMPARATOR
Drug: Ropivacaine

Interventions

RopivacaineDRUG
RopivacaineSaline

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Femoral neck fracture
  • Fracture due to low energy trauma
  • Ability to understand danish and give informed consent
  • Ability to walk before trauma
  • Indication for osteosynthesis
  • ≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points
  • Informed consent

You may not qualify if:

  • Drug or medical abuse
  • Drug intolerance
  • Pathological fractures
  • Inflammatory arthritis
  • Patient included in the study with the contralateral hip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • Bech RD, Lauritsen J, Ovesen O, Emmeluth C, Lindholm P, Overgaard S. Local anaesthetic wound infiltration after internal fixation of femoral neck fractures: a randomized, double-blind clinical trial in 33 patients. Hip Int. 2011 Mar-Apr;21(2):251-9. doi: 10.5301/HIP.2011.6513. Epub 2011 Apr 5.

    PMID: 21484739DERIVED

MeSH Terms

Conditions

Femoral Neck FracturesHip Fractures

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Soren Overgaard, Professor, MD, DmSc

    Odense University Hospital, DK-5000 Odense C, Denmark

    STUDY CHAIR

  • Rune Dueholm Bech, MD

    Odense University Hospital, DK-5000 Odense C, 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

September 12, 2007

First Posted

September 14, 2007

Study Start

January 1, 2008

Study Completion

December 1, 2008

Last Updated

May 6, 2010

Record last verified: 2010-04

Locations

DK(1)