Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type

March 15, 2011 updated by: Odense University Hospital
Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • DK
      • Odense, DK, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Intertrochanteric hip 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Drug: Saline
Approved by the Danish Medicines Agency
Active Comparator: Ropivacaine
Drug: Ropivacaine
Approved by the Danish Medicines Agency
Drug: Saline
Approved by the Danish Medicines Agency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Consumption of opioids
Time Frame: 5 days postoperatively
5 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain
Time Frame: 5 days postoperatively
5 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Study Chair: Soren Overgaard, MD, DmSc, Odense University Hospital, DK-5000 Odense C, Denmark
  • Principal Investigator: Rune Dueholm Bech, MD, Odense University Hospital, DK-5000 Odense C, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Estimate)

March 16, 2011

Last Update Submitted That Met QC Criteria

March 15, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-VF-20060072 - trochanteric

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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