Obturator and Femoral Nerve Block in Patients With Hip Fracture

Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture

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.

Study Overview

• Status: Unknown
• Conditions: Hip Fractures
• Intervention / Treatment: Drug: Bupivacaine; Drug: Saline

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
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Recruiting
    • Aarhus University Hospital
    • Contact: Thomas D. Nielsen, MD; Phone Number: +45 28782877; Email: thomas.dahl.nielsen@clin.au.dk
    • Contact: Thomas F. Bendtsen, MD, Ph.d.; Phone Number: +45 51542997; Email: tfb@dadlnet.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine; Obturator nerve block	Drug: Bupivacaine; Obturator nerve block; Other Names: Active nerve block
Placebo Comparator: Saline; Saline is injected as a placebo	Drug: Saline; Obturator nerve block with saline(placebo); Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median pain score (NRS 0-10)	Median pain score 30 minutes after the nerve blocks compared between the groups	30 minutes
Median change in pain score (NRS 0-10)	Median change in pain score 30 minutes after the nerve blocks compared between the groups	30 minutes
Course in pain reduction	Course in pain reduction during the 30 minutes after the nerve blocks	30 minutes
Time to sufficient analgesia	Time from ended injection until sufficient analgesia	30 minutes
Frequency of anesthesia in the skin area of the saphenous nerve	Frequency of anesthesia in the skin area innervated by the saphenous nerve	30 minutes
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve	Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve	30 minutes
Localization of the worst pain before block	Localization of the worst pain before any nerve blocks	0 minutes
Localization of the worst pain after block	Localization of the worst pain 30 minutes after the nerve blocks	30 minutes
Discomfort during nerve block procedures (score 0-10, 0=no discomfort)	Discomfort during the nerve block procedures compared between procedures	5 minutes
Satisfaction (0-10, 0= very unsatisfactory)	Patient satisfaction with the pain treatment	30 minutes
Frequency of ultrasound visualization of femoral nerve	Frequency of patients with possible ultrasound visualization af the femoral nerve	5 minutes
Frequency of ultrasound visualization of obturator injection site	Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site	5 minutes
Time spend on femoral nerve block	Time spend on conducting the femoral nerve block	5 minutes
Time spend on obturator nerve block	Time spend on conducting the obturator nerve block	5 minutes
Total morphine equivalent dose of opioid from the time of nerve block to operation	Total morphine equivalent dose of opioid from the time of nerve block until the time of operation	Approximately 24 hours in average
Total morphine equivalent dose of opioid/time from the time of nerve block to operation	Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation	Approximately 24 hours in average
Total morphine equivalent dose of opioid in the first 10 hours after nerve block	Total morphine equivalent dose of opioid given in the first 10 hours after nerve block	10 hours
Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block	Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block	10 hours

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Director: Thomas F. Bendtsen, Ph.d., Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: protocol2_2tdn