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Is Regional Anesthesia of the Hip Preferable Over Traditional Analgesia in the Acute Stage of the Management of Patients With a Fracture of the Hip

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01593319
First Posted: May 8, 2012
Last Update Posted: April 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Panagiotis Tsagkozis, Landstinget i Värmland
  Purpose

The main hypothesis of the study is that anaesthesia of the hip using infiltration with a local anesthetic solution is preferable over traditional analgesia with oral opioid medications in the acute stage of the management of patients with a fracture of the hip.

To study the hypothesis the investigators designed a prospective randomised study where patients are assigned in two groups, the first receiving local hip anesthesia and the other placebo treatment. Both groups are eligible to use of standard oral pain treatment.

Effect of analgesia as well as medical complications will be recorded.


Condition Intervention Phase
Hip Fractures Drug: Ropivacaine Drug: Natrium chloride Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Panagiotis Tsagkozis, Landstinget i Värmland:

Primary Outcome Measures:
  • Pain [ Time Frame: 3 hours ]

Secondary Outcome Measures:
  • medical complications (Number of participants that develop pressure ulcers, number of participants that develop pneumonia) [ Time Frame: under hospitalization (expected average of 10 days) ]

Enrollment: 37
Study Start Date: January 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ropivacaine Drug: Ropivacaine
Local injection (fascia iliaca block) using 150 mg ropivacaine
Other Name: Narop
Placebo Comparator: Natrium chloride Drug: Natrium chloride
Placebo injection of Natrium chloride solution

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fracture of the hip

Exclusion Criteria:

  • multiple fractures,
  • delay (more than 12 hours) from the time of injury until admission to the hospital,
  • local infections, hypersensitivity to local analgetics,
  • cognitive impairment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593319


Locations
Sweden
Ortopedkliniken, Centralsjukhuset i Karlstad
Karlstad, Värmland, Sweden, S-65185
Sponsors and Collaborators
Landstinget i Värmland
Investigators
Study Chair: Anders Hallberg, Forskningsschef Centrum för klinisk forskning. Centralsjukhuset, 651 85 Karlstad, Sweden
  More Information

Publications:
Responsible Party: Panagiotis Tsagkozis, MD, PhD, Landstinget i Värmland
ClinicalTrials.gov Identifier: NCT01593319     History of Changes
Other Study ID Numbers: NAROP11
2011-003326-27 ( EudraCT Number )
First Submitted: April 30, 2012
First Posted: May 8, 2012
Last Update Posted: April 21, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents