Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02408419
Other study ID # protocol2tdn
Secondary ID
Status Withdrawn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


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
See also
  Status Clinical Trial Phase
Completed NCT02507609 - Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium N/A
Completed NCT03906864 - Care Pathway for Sub-acute Hip Rehabilitation N/A
Recruiting NCT04063891 - Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients N/A
Completed NCT05039879 - Life Improving Factors After a Hip Fracture
Not yet recruiting NCT03887494 - Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY) N/A
Terminated NCT03065101 - Trigen InterTAN vs Sliding Hip Screw RCT N/A
Completed NCT03545347 - Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture. Phase 2
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05971173 - Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery Early Phase 1
Active, not recruiting NCT04957251 - Anterior vs Posterior Approach for Hip Hemiarthroplasty N/A
Terminated NCT04372966 - Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures N/A
Withdrawn NCT05030688 - Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty N/A
Completed NCT04424186 - 'Rehabilitation for Life' N/A
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Withdrawn NCT05518279 - Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures Phase 3
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Active, not recruiting NCT02247791 - Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty N/A
Completed NCT00746876 - Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. N/A
Completed NCT00058864 - The HIP Impact Protection Program (HIP PRO) N/A