NCT02408419

Brief Summary

About 10-30% of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves occasionally 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 trail is to give patients with hip fracture and only insufficient effect of a femoral nerve block a supplementary obturator nerve block in a randomized manner with either local anesthetics or placebo in order to access the preoperative analgesic effect.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 14, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

March 31, 2015

Last Update Submit

September 11, 2015

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • Success rate of successful analgesia

    Success rate of successful analgesia 20 minutes after a supplementary obturator nerve block in patients with hip fracture

    20 minutes

Secondary Outcomes (3)

  • Time used for the procedure

    Expected average of 5 minutes

  • Success rate of possible sonographic visualization

    Expected average of 5 minutes

  • Time to analgesia

    20 minutes

Study Arms (2)

Local anesthetic

EXPERIMENTAL

15 ml. of local anesthetic

Drug: Bupivacaine

Saline

PLACEBO COMPARATOR

15 ml. of saline

Drug: Saline

Interventions

BupivacaineDRUG

Bupivacaine is injected proximally to anesthetize the obturator nerve

Local anesthetic
SalineDRUG

Saline is injected as a placebo

Also known as: Solution of sodium chloride
Saline

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical suspicion of hip fracture
  • Successful sensory cutaneous effect of the femoral nerve block
  • 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
  • Possible sonographic visualization of the structures needed for the nerve block
  • Patients informed consent

You may not qualify if:

  • Hip fracture not confirmed by x-ray
  • Weight \< 45 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

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: 33238043DERIVED

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, MD, Ph.d.

    Aarhus University Hospital

    STUDY DIRECTOR
0

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

March 31, 2015

First Posted

April 3, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

September 14, 2015

Record last verified: 2015-03

Locations

DK(1)