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

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. Identifier: NCT01593319
Recruitment Status : Terminated
First Posted : May 8, 2012
Last Update Posted : April 21, 2015
Information provided by (Responsible Party):
Panagiotis Tsagkozis, Landstinget i Värmland

Brief Summary:

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 or disease Intervention/treatment Phase
Hip Fractures Drug: Ropivacaine Drug: Natrium chloride Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study Start Date : January 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pain [ Time Frame: 3 hours ]

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

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

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

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 identifier (NCT number): NCT01593319

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

Publications of Results:
Responsible Party: Panagiotis Tsagkozis, MD, PhD, Landstinget i Värmland Identifier: NCT01593319     History of Changes
Other Study ID Numbers: NAROP11
2011-003326-27 ( EudraCT Number )
First Posted: May 8, 2012    Key Record Dates
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
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents