Obturator and Femoral Nerve Block in Patients With Hip Fracture

Hip Fractures Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02540837
• Other study ID #: protocol2_2tdn
• Status: Recruiting
• Phase: Phase 4
• First received: August 27, 2015
• Last updated: May 13, 2016
• Start date: October 2015
• Est. completion date: April 2017

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: Thomas D. Nielsen, M.D.
• Phone: +45 28782877
• Email: thomas.dahl.nielsen[@]clin.au.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• Bupivacaine
Obturator nerve block
• Saline
Obturator nerve block with saline(placebo)

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Median pain score (NRS 0-10)	Median pain score 30 minutes after the nerve blocks compared between the groups	30 minutes	No
Secondary	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	No
Secondary	Course in pain reduction	Course in pain reduction during the 30 minutes after the nerve blocks	30 minutes	No
Secondary	Time to sufficient analgesia	Time from ended injection until sufficient analgesia	30 minutes	No
Secondary	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	No
Secondary	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	No
Secondary	Localization of the worst pain before block	Localization of the worst pain before any nerve blocks	0 minutes	No
Secondary	Localization of the worst pain after block	Localization of the worst pain 30 minutes after the nerve blocks	30 minutes	No
Secondary	Discomfort during nerve block procedures (score 0-10, 0=no discomfort)	Discomfort during the nerve block procedures compared between procedures	5 minutes	No
Secondary	Satisfaction (0-10, 0= very unsatisfactory)	Patient satisfaction with the pain treatment	30 minutes	No
Secondary	Frequency of ultrasound visualization of femoral nerve	Frequency of patients with possible ultrasound visualization af the femoral nerve	5 minutes	No
Secondary	Frequency of ultrasound visualization of obturator injection site	Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site	5 minutes	No
Secondary	Time spend on femoral nerve block	Time spend on conducting the femoral nerve block	5 minutes	No
Secondary	Time spend on obturator nerve block	Time spend on conducting the obturator nerve block	5 minutes	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No