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 is currently recruiting participants.

Verified May 2012 by Landstinget i Värmland

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

History of Changes

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:

MedlinePlus related topics: Fractures Hip Injuries and Disorders

Drug Information available for: Chlorine Ropivacaine monohydrochloride

U.S. FDA Resources

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

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:

Brisbane Orthopaedic & Sports Medicine Centre Writing Committee, McMeniman TJ, McMeniman PJ, Myers PT, Hayes DA, Cavdarski A, Wong MS, Wilson AJ, Jones MA, Watts MC. Femoral nerve block vs fascia iliaca block for total knee arthroplasty postoperative pain control: a prospective, randomized controlled trial. J Arthroplasty. 2010 Dec;25(8):1246-9. Epub 2010 Feb 23.

Candal-Couto JJ, McVie JL, Haslam N, Innes AR, Rushmer J. Pre-operative analgesia for patients with femoral neck fractures using a modified fascia iliaca block technique. Injury. 2005 Apr;36(4):505-10.

Fletcher AK, Rigby AS, Heyes FL. Three-in-one femoral nerve block as analgesia for fractured neck of femur in the emergency department: a randomized, controlled trial. Ann Emerg Med. 2003 Feb;41(2):227-33.

Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8.

Høgh A, Dremstrup L, Jensen SS, Lindholt J. Fascia iliaca compartment block performed by junior registrars as a supplement to pre-operative analgesia for patients with hip fracture. Strategies Trauma Limb Reconstr. 2008 Sep;3(2):65-70. Epub 2008 Sep 2.

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 May 16, 2013

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