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Obturator and Femoral Nerve Block in Patients With Hip Fracture

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ClinicalTrials.gov Identifier: NCT02540837
Recruitment Status : Unknown
Verified May 2016 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : September 4, 2015
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Hip Fractures Drug: Bupivacaine Drug: Saline Phase 4

Detailed Description:

A higher number than expected 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 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. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown.

With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
Study Start Date : October 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bupivacaine
Obturator nerve block
Drug: Bupivacaine
Obturator nerve block
Other Name: Active nerve block

Placebo Comparator: Saline
Saline is injected as a placebo
Drug: Saline
Obturator nerve block with saline(placebo)
Other Name: Placebo




Primary Outcome Measures :
  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. [ Time Frame: 30 minutes ]
    Success rate of successful analgesia compared between the groups


Secondary Outcome Measures :
  1. Median pain score (NRS 0-10) [ Time Frame: 30 minutes ]
    Median pain score 30 minutes after the nerve blocks compared between the groups

  2. Median change in pain score (NRS 0-10) [ Time Frame: 30 minutes ]
    Median change in pain score 30 minutes after the nerve blocks compared between the groups

  3. Course in pain reduction [ Time Frame: 30 minutes ]
    Course in pain reduction during the 30 minutes after the nerve blocks

  4. Time to sufficient analgesia [ Time Frame: 30 minutes ]
    Time from ended injection until sufficient analgesia

  5. Frequency of anesthesia in the skin area of the saphenous nerve [ Time Frame: 30 minutes ]
    Frequency of anesthesia in the skin area innervated by the saphenous nerve

  6. Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve [ Time Frame: 30 minutes ]
    Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve

  7. Localization of the worst pain before block [ Time Frame: 0 minutes ]
    Localization of the worst pain before any nerve blocks

  8. Localization of the worst pain after block [ Time Frame: 30 minutes ]
    Localization of the worst pain 30 minutes after the nerve blocks

  9. Discomfort during nerve block procedures (score 0-10, 0=no discomfort) [ Time Frame: 5 minutes ]
    Discomfort during the nerve block procedures compared between procedures

  10. Satisfaction (0-10, 0= very unsatisfactory) [ Time Frame: 30 minutes ]
    Patient satisfaction with the pain treatment

  11. Frequency of ultrasound visualization of femoral nerve [ Time Frame: 5 minutes ]
    Frequency of patients with possible ultrasound visualization af the femoral nerve

  12. Frequency of ultrasound visualization of obturator injection site [ Time Frame: 5 minutes ]
    Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site

  13. Time spend on femoral nerve block [ Time Frame: 5 minutes ]
    Time spend on conducting the femoral nerve block

  14. Time spend on obturator nerve block [ Time Frame: 5 minutes ]
    Time spend on conducting the obturator nerve block

  15. Total morphine equivalent dose of opioid from the time of nerve block to operation [ Time Frame: Approximately 24 hours in average ]
    Total morphine equivalent dose of opioid from the time of nerve block until the time of operation

  16. Total morphine equivalent dose of opioid/time from the time of nerve block to operation [ Time Frame: Approximately 24 hours in average ]
    Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation

  17. Total morphine equivalent dose of opioid in the first 10 hours after nerve block [ Time Frame: 10 hours ]
    Total morphine equivalent dose of opioid given in the first 10 hours after nerve block

  18. Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block [ Time Frame: 10 hours ]
    Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 numeric pain scale score (NRS 0-10) > 5 with a dynamic test OR NRS > 3 at rest
  • Patients informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540837


Contacts
Contact: Thomas D. Nielsen, M.D. +45 28782877 thomas.dahl.nielsen@clin.au.dk
Contact: Thomas F. Bendtsen, Ph.d. +45 51542997 tfb@dadlnet.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Thomas D. Nielsen, MD    +45 28782877    thomas.dahl.nielsen@clin.au.dk   
Contact: Thomas F. Bendtsen, MD, Ph.d.    +45 51542997    tfb@dadlnet.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Thomas F. Bendtsen, Ph.d. Aarhus University Hospital

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02540837     History of Changes
Other Study ID Numbers: protocol2_2tdn
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents