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Analgesia for Positioning Hip Fracture Patients for Spinal Anesthesia

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Fentanyl
Fascia iliaca compartment block
ropivacaine
Sponsored by
Asklepieion Voulas General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asklepieion Hospital of Voula

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fascia iliaca compartment block

Fentanyl

Arm Description

Outcomes

Primary Outcome Measures

Pain scores on the Numeric Rating Scale

Secondary Outcome Measures

Duration of spinal anesthesia performance
It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
Quality of patient's position
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"

Full Information

First Posted
January 12, 2014
Last Updated
January 15, 2014
Sponsor
Asklepieion Voulas General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02037633
Brief Title
Analgesia for Positioning Hip Fracture Patients for Spinal Anesthesia
Official Title
Fascia Iliaca Compartment Block Versus Fentanyl for Positioning Patients With Hip Fractures for Central Nervous Blockade: a Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asklepieion Voulas General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fascia iliaca compartment block
Arm Type
Active Comparator
Arm Title
Fentanyl
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Fentanyl IV
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca compartment block
Intervention Description
Fascia iliaca compartment block using ropivacaine
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Primary Outcome Measure Information:
Title
Pain scores on the Numeric Rating Scale
Time Frame
Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
Secondary Outcome Measure Information:
Title
Duration of spinal anesthesia performance
Description
It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
Time Frame
Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
Title
Quality of patient's position
Description
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
Time Frame
Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asklepieion Hospital of Voula
City
Athens
State/Province
Attica
ZIP/Postal Code
16673
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
19650803
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.
Results Reference
background
PubMed Identifier
18762870
Citation
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.
Results Reference
background
PubMed Identifier
33238043
Citation
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.
Results Reference
derived

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Analgesia for Positioning Hip Fracture Patients for Spinal Anesthesia

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