Obturator Nerve Block in Patients With Hip Fracture

Hip Fractures Clinical Trial

— OPAD  

Official title:

Proximal Obturator Nerve Block After Insufficient Analgesic Effect of Femoral Nerve Block in Patients With Hip Fracture

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02408419
• Other study ID #: protocol2tdn
• Status: Withdrawn
• Phase: Phase 4
• First received: March 31, 2015
• Last updated: September 11, 2015
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

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
Bupivacaine is injected proximally to anesthetize the obturator nerve
• Saline
Saline is injected as a 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	Success rate of successful analgesia 20 minutes after a supplementary obturator nerve block in patients with hip fracture	20 minutes	No
Secondary	Time used for the procedure	Time from start of ultrasound scanning to end of injection of local anesthetic or placebo	Expected average of 5 minutes	No
Secondary	Success rate of possible sonographic visualization	Success rate of possible sonographic visualization of necessary anatomical structures i order to do the nerve block	Expected average of 5 minutes	No
Secondary	Time to analgesia	Time from end of injection of local anesthetic to analgesia	20 minutes	No