Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture

Hip Fracture Clinical Trial

Official title:

Analgesic Duration af a Preoperative Single-shot Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02248870
• Other study ID #: protocol1tdn
• Status: Terminated
• Phase: Phase 4
• First received: September 18, 2014
• Last updated: September 11, 2015
• Start date: March 2015
• Est. completion date: September 2015

Study information

• Verified date: March 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Dexamethasone
Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection
• Saline
Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Until the start of the operation or at 20 hours, average 18 hours	No
Secondary	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	Until the start of the operation or at 22 hours, average 20 hours	No
Secondary	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	Until the start of the operation or at 24 hours, average 22 hours	No
Secondary	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	Until the start of the operation or at 20 hours, average 18 hours	No
Secondary	Time to wish for opioid analgesia	Mean time fra nerve block to wish for opioid analgesia compared between groups	Until the start of the operation or at 24 hours, average 22 hours	No
Secondary	Use of opioid analgesia until 20 hours	Mean use of opioid analgesia until the time of operation or at 20 hours compared between groups	Until the start of the operation or at 20 hours, average 18 hours	No
Secondary	Use of opioid analgesia until 22 hours	Mean use of opioid analgesia until the time of operation or at 22 hours compared between groups	Until the start of the operation or at 22 hours, average 20 hours	No
Secondary	Use of opioid analgesia until 24 hours	Mean use of opioid analgesia until the time of operation or at 24 hours compared between groups	Until the start of the operation or at 24 hours, average 22 hours	No
Secondary	Time to analgesic effect with patient at rest	Mean time from nerve block to verbal pain score =3 at rest	30 minutes	No
Secondary	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	30 minutes	No
Secondary	Frequency of insufficient analgesia	Frequency of patients with hip fracture with insufficient analgesia after femoral nerve block at 30 minutes	30 minutes	No
Secondary	Frequency of absent analgesia	Frequency of patients with hip fracture with absent analgesia after femoral nerve block at 30 minutes	30 minutes	No
Secondary	Frequency of patients without sufficient analgesia	Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 30 minutes	30 minutes	No
Secondary	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	30 minutes	No
Secondary	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	30 minutes	No
Secondary	Sufficient analgesia Dexamethasone vs. plain	Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain bupivacaine	30 minutes	No
Secondary	Nerve visualization	Frequency of possible ultrasound visualization of the femoral nerve	Just before injection, which is within an expected average of 10 minutes after inclusion	No