A Phase 4 interventional study of Dexamethasone and Saline in Hip Fracture, sponsored by University of Aarhus. Terminated at 1 site in Denmark. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2015-09-14.
Sponsored by University of Aarhus · Phase 4, Interventional, and Treatment
Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24 hours in patients with hip fracture would have a major impact in order to provide better preoperative analgesia for this group.
In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone to the local anesthetics doubled the analgesic duration. No studies has investigated the effect of the addition of Dexamethasone to the femoral nerve block in patients with hip fracture.
The aim of our study is to investigate if more patients with hip fracture experience lasting preoperative analgesia until the time of operation or 20 hours after a femoral nerve block with the addition of Dexamethasone compared to the same nerve block done without Dexamethasone.
Patients with hip fractures are most often old, have multiple comorbidities and suffer severe pain.
Femoral nerve block as a means of preoperative analgesia for these patients has proven effective in multiple trials for the majority of the patients. Still some issues remains to be investigated in order to optimize the preoperative analgesia for this group.
One of the issues that reduces the feasibility of the femoral nerve block is the relatively shorter analgesic duration of the nerve block compared to the often longer time from the hospital admission to the actual operation. From the literature and our own experience the mean analgesic duration of a femoral nerve block approximates 15 hours.
Many studies have shown a prolonged analgesic duration of different nerve blocks when Dexamethasone was added to the local anesthetics. Some studies show a 100 percent increase in duration.
To our knowledge no studies have been published regarding prolongation of the analgesic effect of the femoral nerve block with Dexamethasone, and also none regarding the group of patients with hip fracture.
The clinical impact of a femoral nerve block with an analgesic duration of 20 hours compared to the present 15 hours would be less patients waking up in wards during the night time with pain and a terminated femoral nerve block.
The purpose of this study is to investigate if more patients with hip fracture experience a lasting preoperative analgesic duration of at least 20 hours or until the time of operation after a femoral nerve block with Bupivacaine with adrenaline and the addition of Dexamethasone compared to the same nerve block done with only Bupivacaine with adrenaline.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 7 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Bupivacaine with adrenaline with 2 ml. of Saline added
Drug: Saline
Bupivacaine with adrenaline with 2 ml. of Dexamethasone added
Drug: Dexamethasone
Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection
Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection
Also known as: Solution of sodium chloride
Frequency of analgesia at the time of operation or at 20 hours
Frequency of analgesia at the time of operation or at 20 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
Time frame: Until the start of the operation or at 20 hours, average 18 hours
Frequency of analgesia at the time of operation or at 22 hours
Frequency of analgesia at the time of operation or at 22 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
Time frame: Until the start of the operation or at 22 hours, average 20 hours
Frequency of analgesia at the time of operation or at 24 hours
Frequency of analgesia at the time of operation or at 24 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
Time frame: Until the start of the operation or at 24 hours, average 22 hours
Frequency of satisfactory analgesia
Frequency of patients with satisfactory analgesia i the period from the nerve block until the time of operation or at 20 hours compared between the groups
Time frame: Until the start of the operation or at 20 hours, average 18 hours
Time to wish for opioid analgesia
Mean time fra nerve block to wish for opioid analgesia compared between groups
Time frame: Until the start of the operation or at 24 hours, average 22 hours
Use of opioid analgesia until 20 hours
Mean use of opioid analgesia until the time of operation or at 20 hours compared between groups
Time frame: Until the start of the operation or at 20 hours, average 18 hours
Use of opioid analgesia until 22 hours
Mean use of opioid analgesia until the time of operation or at 22 hours compared between groups
Time frame: Until the start of the operation or at 22 hours, average 20 hours
Use of opioid analgesia until 24 hours
Mean use of opioid analgesia until the time of operation or at 24 hours compared between groups
Time frame: Until the start of the operation or at 24 hours, average 22 hours
Time to analgesic effect with patient at rest
Mean time from nerve block to verbal pain score ≤3 at rest
Time frame: 30 minutes
Time to analgesic effect measured while doing passive leg raise
Mean time from nerve block to verbal pain score ≤5 while doing passive leg raise
Time frame: 30 minutes
Frequency of insufficient analgesia
Frequency of patients with hip fracture with insufficient analgesia after femoral nerve block at 30 minutes
Time frame: 30 minutes
Frequency of absent analgesia
Frequency of patients with hip fracture with absent analgesia after femoral nerve block at 30 minutes
Time frame: 30 minutes
Frequency of patients without sufficient analgesia
Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 30 minutes
Time frame: 30 minutes
Skin sensation in saphenous area
Frequency of reduced cold sensation in the skin area innervated by the saphenous nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block
Time frame: 30 minutes
Skin sensation in area of the anterior cutaneous branches of the femoral nerve
Frequency of reduced cold sensation in the skin area innervated by the anterior cutaneous branches of the femoral nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block
Time frame: 30 minutes
Sufficient analgesia Dexamethasone vs. plain
Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain bupivacaine
Time frame: 30 minutes
Nerve visualization
Frequency of possible ultrasound visualization of the femoral nerve
Time frame: Just before injection, which is within an expected average of 10 minutes after inclusion
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University of Aarhus