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 recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Landstinget i Värmland.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Panagiotis Tsagkozis, Landstinget i Värmland
ClinicalTrials.gov Identifier:
NCT01593319
First received: April 30, 2012
Last updated: May 7, 2012
Last verified: May 2012
  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: 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 ]

Estimated Enrollment: 132
Study Start Date: January 2012
Estimated Primary Completion Date: January 2013 (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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593319

Contacts
Contact: Catharina Nelson, MD 004654615000 catharina_nelson@telia.com
Contact: Panagiotis Tsagkozis, MD, PhD 004654615000 tsagozis@gmail.com

Locations
Sweden
Ortopedkliniken, Centralsjukhuset i Karlstad Recruiting
Karlstad, Värmland, Sweden, S-65185
Contact: Catharina Nelson, MD    0046 54 615000    catharina_nelson@telia.com   
Principal Investigator: Panagiotis Tsagkozis, MD, PhD         
Sub-Investigator: Catharina Nelson, MD         
Sub-Investigator: Rolf Norlin, Professor         
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
Study First Received: April 30, 2012
Last Updated: May 7, 2012
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014