Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture
Primary Purpose
Hip Fracture
Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Dexamethasone
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fracture focused on measuring femoral neck
Eligibility Criteria
Inclusion Criteria:
- Clinical suspicion of hip fracture
- Age ≥ 55 years
- Mentally capable of comprehending and using verbal pain score
- Mentally capable of differentiating between pain from the fractured hip and pain from other locations
- Mentally capable of understanding the given information
- Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
- Verbal pain score (0-10) ≥ 7 with passive leg raise of the fractured leg at the time of inclusion
- Patients informed consent
Exclusion Criteria:
- Hip fracture not confirmed by x-ray
- Weight < 40 kg
- Verbal pain score > 3, 30 minutes after the nerve block
- Verbal pain score > 5 with passive leg raise, 30 minutes after the nerve block
- Patient has previously been included in this trial
- Ongoing pre traumatic treatment with parenteral or intravenous adrenocortical hormone
- Verbal pain score > 3 from other locations than the fractured hip
- If the patient wishes to be excluded
- Allergy to local anesthetics or adrenocortical hormone
- Visible infection in the area of the point of needle injection
- Acute inability to comprehend and use verbal pain score
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Saline
Dexamethasone
Arm Description
Bupivacaine with adrenaline with 2 ml. of Saline added
Bupivacaine with adrenaline with 2 ml. of Dexamethasone added
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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 to wish for opioid analgesia
Mean time fra nerve block to wish for opioid analgesia compared between groups
Use of opioid analgesia until 20 hours
Mean use of opioid analgesia until the time of operation or at 20 hours compared between groups
Use of opioid analgesia until 22 hours
Mean use of opioid analgesia until the time of operation or at 22 hours compared between groups
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 to analgesic effect with patient at rest
Mean time from nerve block to verbal pain score ≤3 at rest
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
Frequency of insufficient analgesia
Frequency of patients with hip fracture with insufficient analgesia after femoral nerve block at 30 minutes
Frequency of absent analgesia
Frequency of patients with hip fracture with absent analgesia after femoral nerve block at 30 minutes
Frequency of patients without sufficient analgesia
Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 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
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
Sufficient analgesia Dexamethasone vs. plain
Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain bupivacaine
Nerve visualization
Frequency of possible ultrasound visualization of the femoral nerve
Full Information
NCT ID
NCT02248870
First Posted
September 18, 2014
Last Updated
September 11, 2015
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT02248870
Brief Title
Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture
Official Title
Analgesic Duration af a Preoperative Single-shot Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Less inclusions than expected with the given criteria
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
femoral neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Bupivacaine with adrenaline with 2 ml. of Saline added
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Bupivacaine with adrenaline with 2 ml. of Dexamethasone added
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Solution of sodium chloride
Intervention Description
Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection
Primary Outcome Measure Information:
Title
Frequency of analgesia at the time of operation or at 20 hours
Description
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
Secondary Outcome Measure Information:
Title
Frequency of analgesia at the time of operation or at 22 hours
Description
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
Title
Frequency of analgesia at the time of operation or at 24 hours
Description
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
Title
Frequency of satisfactory analgesia
Description
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
Title
Time to wish for opioid analgesia
Description
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
Title
Use of opioid analgesia until 20 hours
Description
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
Title
Use of opioid analgesia until 22 hours
Description
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
Title
Use of opioid analgesia until 24 hours
Description
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
Title
Time to analgesic effect with patient at rest
Description
Mean time from nerve block to verbal pain score ≤3 at rest
Time Frame
30 minutes
Title
Time to analgesic effect measured while doing passive leg raise
Description
Mean time from nerve block to verbal pain score ≤5 while doing passive leg raise
Time Frame
30 minutes
Title
Frequency of insufficient analgesia
Description
Frequency of patients with hip fracture with insufficient analgesia after femoral nerve block at 30 minutes
Time Frame
30 minutes
Title
Frequency of absent analgesia
Description
Frequency of patients with hip fracture with absent analgesia after femoral nerve block at 30 minutes
Time Frame
30 minutes
Title
Frequency of patients without sufficient analgesia
Description
Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 30 minutes
Time Frame
30 minutes
Title
Skin sensation in saphenous area
Description
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
Title
Skin sensation in area of the anterior cutaneous branches of the femoral nerve
Description
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
Title
Sufficient analgesia Dexamethasone vs. plain
Description
Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain bupivacaine
Time Frame
30 minutes
Title
Nerve visualization
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical suspicion of hip fracture
Age ≥ 55 years
Mentally capable of comprehending and using verbal pain score
Mentally capable of differentiating between pain from the fractured hip and pain from other locations
Mentally capable of understanding the given information
Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
Verbal pain score (0-10) ≥ 7 with passive leg raise of the fractured leg at the time of inclusion
Patients informed consent
Exclusion Criteria:
Hip fracture not confirmed by x-ray
Weight < 40 kg
Verbal pain score > 3, 30 minutes after the nerve block
Verbal pain score > 5 with passive leg raise, 30 minutes after the nerve block
Patient has previously been included in this trial
Ongoing pre traumatic treatment with parenteral or intravenous adrenocortical hormone
Verbal pain score > 3 from other locations than the fractured hip
If the patient wishes to be excluded
Allergy to local anesthetics or adrenocortical hormone
Visible infection in the area of the point of needle injection
Acute inability to comprehend and use verbal pain score
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F. Bendtsen, MD, Ph.d.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
33238043
Citation
Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Results Reference
derived
Learn more about this trial
Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture
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