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

Sponsor
Changi General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02330302
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Femoral nerve block

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

Drug: Ropivacaine
Ultrasound-guided femoral nerve block with Ropivacaine 0.5% 30mls
Other Names:
  • naropin

    		•
    Active Comparator: Fascia Iliaca block

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

    Drug: Ropivacaine
    Ultrasound-guided suprainguinal approach to fascia iliaca block with Ropivacaine 0.5% 30mls
    Other Names:
  • naropin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain scores [up to 24 hours]

      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

    1. opioid requirement/consumption [for first 24 hrs (including intra operatively) following intervention]

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

    Other Outcome Measures

    1. complications associated with intervention [at 24 hrs post intervention]

      including hematoma, infection, prolonged neurologic deficits, occurence of falls

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Changi General Hospital Singapore Singapore 529889

    Sponsors and Collaborators

    • Changi General Hospital

    Investigators

    • Principal Investigator: Yean Chin Lim, MBBS, MMed, Changi General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Changi General Hospital
    ClinicalTrials.gov Identifier:
    NCT02330302
    Other Study ID Numbers:
    • 2014/453/D
    First Posted:
    Jan 1, 2015
    Last Update Posted:
    Jan 25, 2018
    Last Verified:
    Jan 1, 2018
    Additional relevant MeSH terms:
    Fractures, Bone
    Hip Fractures
    Ropivacaine

    Study Results

    No Results Posted as of Jan 25, 2018