NCT01593319

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

3.2 years

First QC Date

April 30, 2012

Last Update Submit

April 17, 2015

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • Pain

    3 hours

Secondary Outcomes (1)

  • medical complications (Number of participants that develop pressure ulcers, number of participants that develop pneumonia)

    under hospitalization (expected average of 10 days)

Study Arms (2)

ropivacaine

ACTIVE COMPARATOR
Drug: Ropivacaine

Natrium chloride

PLACEBO COMPARATOR
Drug: Natrium chloride

Interventions

RopivacaineDRUG

Local injection (fascia iliaca block) using 150 mg ropivacaine

Also known as: Narop
ropivacaine
Natrium chlorideDRUG

Placebo injection of Natrium chloride solution

Natrium chloride

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • fracture of the hip

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ortopedkliniken, Centralsjukhuset i Karlstad

Karlstad, Värmland County, S-65185, Sweden

Location

Related Publications (6)

  • 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. doi: 10.1016/j.arth.2009.11.018. Epub 2010 Feb 23.

    PMID: 20178889RESULT

  • 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. doi: 10.1016/j.injury.2004.10.015.

    PMID: 15755432RESULT

  • 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. doi: 10.1067/mem.2003.51.

    PMID: 12548273RESULT

  • 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. doi: 10.1097/01.anes.0000264764.56544.d2.

    PMID: 17413915RESULT

  • Hogh 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. doi: 10.1007/s11751-008-0037-9. Epub 2008 Sep 2.

    PMID: 18762870RESULT

  • Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

    PMID: 33238043DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Anders Hallberg, Forskningsschef

    Centrum för klinisk forskning. Centralsjukhuset, 651 85 Karlstad, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 8, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

SE(1)