OPAD: Obturator Nerve Block in Patients With Hip Fracture

Sponsor
University of Aarhus (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02408419
Collaborator
(none)
0
1
2
24
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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. 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 af the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Proximal Obturator Nerve Block After Insufficient Analgesic Effect of Femoral Nerve Block in Patients With Hip Fracture
Study Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Local anesthetic

15 ml. of local anesthetic

Drug: Bupivacaine
Bupivacaine is injected proximally to anesthetize the obturator nerve

Placebo Comparator: Saline

15 ml. of saline

Drug: Saline
Saline is injected as a placebo
Other Names:
  • Solution of sodium chloride
  • Outcome Measures

    Primary Outcome Measures

    1. Success rate of successful analgesia [20 minutes]

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

    Secondary Outcome Measures

    1. Time used for the procedure [Expected average of 5 minutes]

      Time from start of ultrasound scanning to end of injection of local anesthetic or placebo

    2. Success rate of possible sonographic visualization [Expected average of 5 minutes]

      Success rate of possible sonographic visualization of necessary anatomical structures i order to do the nerve block

    3. Time to analgesia [20 minutes]

      Time from end of injection of local anesthetic to analgesia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    • Verbal numeric pain scale score (NRS 0-10) > 5 with passive leg raise of the fractured leg at the time of inclusion OR NRS > 3 at rest, 30 minutes after a femoral nerve block

    • Patients informed consent

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital Aarhus Denmark 8000

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    • Study Director: Thomas F. Bendtsen, MD, Ph.d., Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT02408419
    Other Study ID Numbers:
    • protocol2tdn
    First Posted:
    Apr 3, 2015
    Last Update Posted:
    Sep 14, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2015