Obturator Nerve Block in Patients With Hip Fracture (OPAD)

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

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.

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital

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
• 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 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Time to analgesia	Time from end of injection of local anesthetic to analgesia	20 minutes

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Estimate): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: March 1, 2015

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: protocol2tdn