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.
Information provided by (Responsible Party):
Panagiotis Tsagkozis, Landstinget i Värmland Identifier:
First received: April 30, 2012
Last updated: April 17, 2015
Last verified: April 2015

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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Resource links provided by NLM:

Further study details as provided by Landstinget i Värmland:

Primary Outcome Measures:
  • Pain [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Panagiotis Tsagkozis, MD, PhD, Landstinget i Värmland Identifier: NCT01593319     History of Changes
Other Study ID Numbers: NAROP11  2011-003326-27 
Study First Received: April 30, 2012
Last Updated: April 17, 2015
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Hip Fractures
Femoral Fractures
Fractures, Bone
Hip Injuries
Leg Injuries
Wounds and Injuries
Anesthetics, Local
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 23, 2016