An interventional study of Placebo and Bupivacaine in Proximal Femur Fractures, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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
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.
Mansoura University is the lead sponsor of 1,114 studies on the registry; 184 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.
Drug: Placebo · Device: Ultrasound guided fascia iliaca compartment block · Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)
Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.
Drug: Bupivacaine · Device: Ultrasound guided fascia iliaca compartment block · Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)
Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml
Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml
Ultrasound guided fascia iliaca compartment block
Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms
Pain scores
Pain was assessed using visual analogue score
Time frame: For 24 hours after performance the blockade
Heart rate
Time frame: For 24 hours after performance the blockade
Blood pressure
Time frame: For 24 hours after performance the blockade
Peripheral oxygen saturation
Time frame: For 24 hours after performance the blockade
Time to performing spinal anesthesia
Time from the placement of patient in the optimum position to the intra-thecal injection of bupivacaine
Time frame: For 30 min after placement of patient in the optimum position
Number of trials of dural puncture
Time frame: For 30 min after placement of patient in the optimum position
Duration of motor blockade
Time frame: For 12 hours after performing spinal anesthesia
Duration of sensory blockade
Time frame: For 12 hours after performing spinal anesthesia
Duration of analgesia
Time from performing spinal anesthesia to first analgesic request
Time frame: For 24 hours after performing spinal anesthesia
Cumulative consumption of analgesics
Total opioid or other analgesics received for the first 24 hours after surgery.
Time frame: For 24 hours after performing spinal anesthesia
Plan to share: Undecided
The record gives a start of Jan 2015, a primary completion of Jul 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine
Proximal Femoral Fractures