Analgesia for Positioning Hip Fracture Patients for Spinal Anesthesia

Hip Fracture Clinical Trial

Official title:

Fascia Iliaca Compartment Block Versus Fentanyl for Positioning Patients With Hip Fractures for Central Nervous Blockade: a Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037633
• Other study ID #: 478-9227/25-7-2012
• Status: Completed
• Phase: N/A
• First received: January 12, 2014
• Last updated: January 15, 2014
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Asklepieion Voulas General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two analgesic methods performed preoperatively to assist positioning patients for performance of spinal anesthesia, namely fascia iliaca blockade and intravenous fentanyl.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hip fracture

Exclusion Criteria:

• contraindications for central nervous blockade

• impaired cognition or dementia

• multiple fractures

• any previous analgesic administration during the last 12 hours

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Fentanyl
Fentanyl IV

Procedure:
• Fascia iliaca compartment block
Fascia iliaca compartment block using ropivacaine

Drug:
• ropivacaine

Locations

Country	Name	City	State
Greece	Asklepieion Hospital of Voula	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Asklepieion Voulas General Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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/s11751-008-0037-9. Epub 2008 Sep 2. — View Citation

Yun MJ, Kim YH, Han MK, Kim JH, Hwang JW, Do SH. Analgesia before a spinal block for femoral neck fracture: fascia iliaca compartment block. Acta Anaesthesiol Scand. 2009 Nov;53(10):1282-7. doi: 10.1111/j.1399-6576.2009.02052.x. Epub 2009 Jul 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores on the Numeric Rating Scale		Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)	No
Secondary	Duration of spinal anesthesia performance	It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal	Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)	No
Secondary	Quality of patient's position	The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"	Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)	No