NCT02540837

Brief Summary

A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve. The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

August 27, 2015

Last Update Submit

May 13, 2016

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.

    Success rate of successful analgesia compared between the groups

    30 minutes

Secondary Outcomes (18)

  • Median pain score (NRS 0-10)

    30 minutes

  • Median change in pain score (NRS 0-10)

    30 minutes

  • Course in pain reduction

    30 minutes

  • Time to sufficient analgesia

    30 minutes

  • Frequency of anesthesia in the skin area of the saphenous nerve

    30 minutes

  • +13 more secondary outcomes

Study Arms (2)

Bupivacaine

EXPERIMENTAL

Obturator nerve block

Drug: Bupivacaine

Saline

PLACEBO COMPARATOR

Saline is injected as a placebo

Drug: Saline

Interventions

BupivacaineDRUG

Obturator nerve block

Also known as: Active nerve block
Bupivacaine
SalineDRUG

Obturator nerve block with saline(placebo)

Also known as: Placebo
Saline

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Verbal numeric pain scale score (NRS 0-10) \> 5 with a dynamic test OR NRS \> 3 at rest
  • Patients informed consent

You may not qualify if:

  • Hip fracture not confirmed by x-ray
  • Weight \< 40 kg
  • Patient has previously been included in this trial
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Thomas F. Bendtsen, Ph.d.

    Aarhus University Hospital

    STUDY DIRECTOR

Central Study Contacts

Thomas D. Nielsen, M.D.

CONTACT

+45 28782877thomas.dahl.nielsen@clin.au.dk

Thomas F. Bendtsen, Ph.d.

CONTACT

+45 51542997tfb@dadlnet.dk

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

August 27, 2015

First Posted

September 4, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 16, 2016

Record last verified: 2016-05

Locations

DK(1)