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Single Shot Fascia Iliaca Block vs Femoral Nerve Block for Analgesia for Surgical Fixation of Hip Fractures

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Ropivacaine
Ropivacaine
Sponsored by
Changi 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:

  • Patients scheduled for surgical fixation of hip fracture
  • Patients with isolated inter-trochantric fracture
  • American Society of Anesthesiologists (ASA) physical status 1 to 3
  • Patients who are able to give their own consent

Exclusion Criteria:

  • Patients unable to give consent or inability to communicate/ cooperate
  • Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
  • Patients with allergy to local anaesthetics or any drugs included in the study
  • Patients with contraindications to spinal anaesthesia such as coagulation disorders/ thrombocytopenia and local infection at site of injection

Sites / Locations

  • Changi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Femoral nerve block

Fascia Iliaca block

Arm Description

Procedure: Ultrasound-guided femoral nerve block Drug: Ropivacaine 0.5% 30mls

Procedure: Ultrasound-guided suprainguinal approach to fascia iliaca block Drug: Ropivacaine 0.5% 30mls

Outcomes

Primary Outcome Measures

Pain scores
resting and dynamic pain scores are obtained pre-intervention, 30mins post intervention (and on positioning for spinal anaesthesia), 1 hr post-operatively and at 24hrs post intervention

Secondary Outcome Measures

opioid requirement/consumption
need for additional opioids during first 24hrs following intervention record of any opioid related side effects will be kept as well

Full Information

First Posted
December 31, 2014
Last Updated
January 23, 2018
Sponsor
Changi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02330302
Brief Title
Single Shot Fascia Iliaca Block vs Femoral Nerve Block for Analgesia for Surgical Fixation of Hip Fractures
Official Title
A Randomized Controlled Trial Comparing Single Shot Fascia Iliaca Block With Femoral Nerve Block for Analgesia Following Surgical Fixation of Hip Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changi General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hip fractures are common in our elderly population and is associated with pain before and after surgery. The current pain management for patients who have undergone surgery for hip fractures include a combination of oral painkillers, opioids (eg morphine) and regional anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves supplying the hip joint to numb the operation site. As opioids have many side effects, especially in the elderly patients, regional anaesthesia techniques can help to reduce the use of opioids and the related side effects. This may enhance their recovery and length of hospital stay

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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral nerve block
Arm Type
Active Comparator
Arm Description
Procedure: Ultrasound-guided femoral nerve block Drug: Ropivacaine 0.5% 30mls
Arm Title
Fascia Iliaca block
Arm Type
Active Comparator
Arm Description
Procedure: Ultrasound-guided suprainguinal approach to fascia iliaca block Drug: Ropivacaine 0.5% 30mls
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
naropin
Intervention Description
Ultrasound-guided femoral nerve block with Ropivacaine 0.5% 30mls
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
naropin
Intervention Description
Ultrasound-guided suprainguinal approach to fascia iliaca block with Ropivacaine 0.5% 30mls
Primary Outcome Measure Information:
Title
Pain scores
Description
resting and dynamic pain scores are obtained pre-intervention, 30mins post intervention (and on positioning for spinal anaesthesia), 1 hr post-operatively and at 24hrs post intervention
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
opioid requirement/consumption
Description
need for additional opioids during first 24hrs following intervention record of any opioid related side effects will be kept as well
Time Frame
for first 24 hrs (including intra operatively) following intervention
Other Pre-specified Outcome Measures:
Title
complications associated with intervention
Description
including hematoma, infection, prolonged neurologic deficits, occurence of falls
Time Frame
at 24 hrs post intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for surgical fixation of hip fracture Patients with isolated inter-trochantric fracture American Society of Anesthesiologists (ASA) physical status 1 to 3 Patients who are able to give their own consent Exclusion Criteria: Patients unable to give consent or inability to communicate/ cooperate Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids Patients with allergy to local anaesthetics or any drugs included in the study Patients with contraindications to spinal anaesthesia such as coagulation disorders/ thrombocytopenia and local infection at site of injection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yean Chin Lim, MBBS, MMed
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore

12. IPD Sharing Statement

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Single Shot Fascia Iliaca Block vs Femoral Nerve Block for Analgesia for Surgical Fixation of Hip Fractures

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