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

Hip Fractures Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01593319
• Other study ID #: NAROP11
• Secondary ID: 2011-003326-27
• Status: Terminated
• Phase: Phase 4
• First received: April 30, 2012
• Last updated: April 17, 2015
• Start date: January 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Landstinget i Värmland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hip Fractures

Intervention

Drug:
• Ropivacaine
Local injection (fascia iliaca block) using 150 mg ropivacaine
• Natrium chloride
Placebo injection of Natrium chloride solution

Locations

Country	Name	City	State
Sweden	Ortopedkliniken, Centralsjukhuset i Karlstad	Karlstad	Värmland

Sponsors (1)

Lead Sponsor	Collaborator
Landstinget i Värmland

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1007/s11751 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		3 hours	No
Secondary	medical complications (Number of participants that develop pressure ulcers, number of participants that develop pneumonia)		under hospitalization (expected average of 10 days)	No