Obturator Nerve Block in Patients With Hip Fracture

NCT ID: NCT02408419

Last Updated: 2015-09-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-03-31

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.

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Local anesthetic

15 ml. of local anesthetic

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Bupivacaine is injected proximally to anesthetize the obturator nerve

Saline

15 ml. of saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline is injected as a placebo

Interventions

Bupivacaine

Bupivacaine is injected proximally to anesthetize the obturator nerve

Intervention Type: DRUG

Saline

Saline is injected as a placebo

Intervention Type: DRUG

Other Intervention Names

Solution of sodium chloride

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas F. Bendtsen, MD, Ph.d.

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, Aarhus, Denmark

Countries

Denmark

References

Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

Reference Type: DERIVED

PMID: 33238043 (View on PubMed)

Other Identifiers

protocol2tdn

Identifier Type: -

Identifier Source: org_study_id