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Clinical Trials/NCT02696915
NCT02696915
Completed
Not Applicable

Fascia Iliaca Compartment Block in Proximal End Femur Fractures, Does it Make a Difference?

Mansoura University1 site in 1 country60 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Placebo
Conditions
Proximal Femur Fractures
Sponsor
Mansoura University
Enrollment
60
Locations
1
Primary Endpoint
Pain scores
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Fracture femur is a common injury which is associated with excruciating pain. Positioning for neuraxial blocks is always challenging because even slight overriding of the fracture ends is intensely painful .It can causing major patient distress which accompanied by well-known physiological sequelae such as sympathetic activation causing tachycardia, hypotension, and increased cardiac work that may compromise high-risk cardiac patients.

Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but it is also associated with minimal risk as the local anesthetic is injected at a safe distance from the femoral artery and femoral nerve. It is always safe to perform the fascia iliaca compartment block prior to spinal anesthesia as the patient can respond during administration of the local anesthetic and can prevent intra-neuronal injections

Detailed Description

On arrival to the pre-operative holding area half hour before the scheduled surgery. Patient will be connected to basal monitoring devices; pulse oximetry and non- invasive blood pressure. Fascia iliaca compartment block will be performed with the aid of ultrasound device in all cases.The injected local anesthetic solution will be prepared by a staff member who was not involved in the study) according to the randomization. After 20 minutes from the injection the investigators will assessed nerves that had been blocked. On arrival to the operative theater, under complete aseptic technique spinal anesthesia will be carried out in the sitting position (if there is severe pain at positioning we will use lateral position) at space between L3-4 or L4-5 using a 25-gauge spinal quincke needle. After feeling the desired space, the needle will be advanced (paramedian approach) till free flow of cerebrospinal fluid dropped from the needle then 15 mg hyperbaric bupivacaine+20mic fentanyl will be injected.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologist physical status I to III
  • Patients scheduled for fixation for proximal end femur fracture

Exclusion Criteria

  • Patients refusal
  • Morbid obese patients (BMI\>40)
  • Bleeding diathesis
  • Previous femoral bypass surgery
  • Inguinal hernia
  • Inflammation/infection over injection site
  • Peripheral neuropathy
  • Allergy to local anesthetics agents used.
  • Severely altered consciousness level
  • Psychiatric disorders

Arms & Interventions

Placebo

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.

Intervention: Placebo

Placebo

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.

Intervention: Ultrasound guided fascia iliaca compartment block

Placebo

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.

Intervention: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)

Bupivacaine

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.

Intervention: Bupivacaine

Bupivacaine

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.

Intervention: Ultrasound guided fascia iliaca compartment block

Bupivacaine

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.

Intervention: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)

Outcomes

Primary Outcomes

Pain scores

Time Frame: For 24 hours after performance the blockade

Pain was assessed using visual analogue score

Secondary Outcomes

  • Duration of sensory blockade(For 12 hours after performing spinal anesthesia)
  • Duration of analgesia(For 24 hours after performing spinal anesthesia)
  • Cumulative consumption of analgesics(For 24 hours after performing spinal anesthesia)
  • Heart rate(For 24 hours after performance the blockade)
  • Blood pressure(For 24 hours after performance the blockade)
  • Peripheral oxygen saturation(For 24 hours after performance the blockade)
  • Time to performing spinal anesthesia(For 30 min after placement of patient in the optimum position)
  • Number of trials of dural puncture(For 30 min after placement of patient in the optimum position)
  • Duration of motor blockade(For 12 hours after performing spinal anesthesia)

Study Sites (1)

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