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

NCT02248870 | Terminated Phase 4 DMC

• 1 other identifier: protocol1tdn
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fracture

Keywords

femoral neck

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• Frequency of analgesia at the time of operation or at 22 hours

  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

  Until the start of the operation or at 24 hours, average 22 hours

• Frequency of satisfactory analgesia

  Until the start of the operation or at 20 hours, average 18 hours

• Time to wish for opioid analgesia

  Until the start of the operation or at 24 hours, average 22 hours

• Use of opioid analgesia until 20 hours

  Until the start of the operation or at 20 hours, average 18 hours

Study Arms (2)

Saline

PLACEBO COMPARATOR

Bupivacaine with adrenaline with 2 ml. of Saline added

Drug: Saline

Dexamethasone

EXPERIMENTAL

Bupivacaine with adrenaline with 2 ml. of Dexamethasone added

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection

Dexamethasone

Saline DRUG

Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection

Also known as: Solution of sodium chloride

Saline

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 33238043 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Thomas F. Bendtsen, MD, Ph.d.

  Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 25, 2014
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 14, 2015

Record last verified: 2015-03

Locations

DK (1)