search
Back to results

Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Hip Surgery

Primary Purpose

Fractured Neck of Femur

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Femoral nerve block
Sponsored by
Cork University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractured Neck of Femur

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fractured neck of femur surgical fixation performed under spinal anaesthesia
  • ASA I to III

Exclusion Criteria:

  • Patient refusal
  • Coagulation disorders
  • Head injury or other associated injuries
  • Previous vascular surgery in the femoral area.
  • Loss of consciousness and signs of acute coronary syndrome
  • Mini-Mental Score < 25 (see appendix 3)
  • Allergy to lignocaine,
  • Skin lesions/infection at site of injection
  • Sepsis

Sites / Locations

  • Cork University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Above the femoral nerve

Below the femoral nerve

Circumferential

Arm Description

In Group I we will inject the local anaesthetic below the fascia iliaca and above the femoral nerve.

In Group II we will inject the local anaesthetic below the femoral nerve and above the fascia of the iliopsoas muscle.

In Group III a circumferential spread will be achieved with multiple injections.

Outcomes

Primary Outcome Measures

Verbal rating scale (VRS) pain scores after positioning the patient to performing the spinal anaesthesia.
Independent blinded observer will assess the patient in the first 30 minutes, in every 5 minute. Sensory perception will be assess by using cold spray in the area of the terminal branch of femoral nerve. We will assess the pain on passive movement of the limb (elevating 30 degree) using verbal rating scale (VRS) pain score 1-10. When the patient reports less than 4 at the VRS the patient will be positioned for spinal anaesthesia. If the threshold isn't achieved by 30 minutes, the block will be classified as failure. Additional opioid medication and/or sedation will be administered.

Secondary Outcome Measures

Sensory distribution of the nerve block.
An independent blinded observer (not present during block placement) will assess in the first 30 minutes (at 5 minute intervales) the sensory nerve block using a modified Bromage score. Sensory perception will be assessed using cold (ethyl chloride spray) in the area of the vastus medialis, vastus intermedius, vastus lateralis and saphenous nerve innervation area (terminal branch of femoral nerve).
Number of needle passes
The Anaesthestist who performing the femoral nerve block was asked how many needle passes needed for the femoral nerve block.
Femoral nerve block onset time
We will assess the pain on passive movement of the limb (elevating 30 degree from the initial positioning) using verbal rating scale (VRS) pain score 1-10. When the patient reports less than 4 at the VRS the sensory block will be deemed adequate and the patient will be positioned on the side for spinal anaesthesia.
Patient satisfaction
After the surgery during the recovery time, we will ask the patients regarding there Satisfaction, will be used visual analog scale 0-100 mm for measurement.

Full Information

First Posted
February 1, 2012
Last Updated
March 31, 2012
Sponsor
Cork University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01527812
Brief Title
Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Hip Surgery
Official Title
Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Operative Fixation of Fractured Neck of Femur
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cork University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound guided femoral nerve block using the following endpoints: circumferential spread, anterior or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for operative fixation of fractured neck of femur.
Detailed Description
Fractured neck of femur is a common cause of admission to hospital in elderly patients and requires operative fixation. The recommended anaesthetic technique for these cases is spinal anaesthesia, which is performed with the patient in lateral decubitus. Positioning the patient prior to administering spinal anaesthesia is the most painful manouvre due to the movement of the fractured bone. Regional anaesthesia is effective in alleviating pain due to trauma, and it has the advantage of producing localized but complete pain relief (1). Femoral nerve blockade prior to positioning for spinal anaesthesia provides excellent pain relief and is a well tolerated procedure (2-5). Using ultrasound guided femoral nerve block is a relative new method to improving the block success rate. It is widely used in our hospital. In a recent study Casati and al. showed a 42 % decrease of ED50% using ultrasound for localization of the femoral nerve (6). In a recent editorial by Brian D. Sites was mentioned that the positioning of the local anaesthetic in ultrasound guided blocks is unclear (7). We currently follow different patterns in relation to injection of the local anaesthetic solution around the femoral nerve. One of them is a circumferencial spread around the nerve. This, however, needs several needle passes which are likely to be painful for the patient. Another option is injecting the local anaesthetic on one side, above or below the nerve without changing the position of the tip of the needle, avoiding patient discomfort. Whether this results in a comparable quality of sensory block is unknown. The femoral nerve is separated in branches at this level and we assume that the spread of local anaesthetic may influence the quality and the distribution of the block. We propose to study the characteristics of femoral nerve block in relation to different patterns of local anaesthetic injection (circumferencial, inferior or superior).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractured Neck of Femur

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Above the femoral nerve
Arm Type
Experimental
Arm Description
In Group I we will inject the local anaesthetic below the fascia iliaca and above the femoral nerve.
Arm Title
Below the femoral nerve
Arm Type
Experimental
Arm Description
In Group II we will inject the local anaesthetic below the femoral nerve and above the fascia of the iliopsoas muscle.
Arm Title
Circumferential
Arm Type
Experimental
Arm Description
In Group III a circumferential spread will be achieved with multiple injections.
Intervention Type
Procedure
Intervention Name(s)
Femoral nerve block
Intervention Description
We will perform an ultrasound guided femoral nerve block. For locating the nerve a 5 cm, 6-13 MHz linear probe (Sonosite Turbo M, Bothwell WA, USA) will be used. After the examination of the anatomy of the femoral artery we will fix the probe transversal to the thigh below the inguinal crease and above the ramification of deep femoral artery and make skin marks on this position. A 22 G 50 mm long Stimuplex BBraun needle will be used. 15 ml 2 % lignocaine will be injected.
Primary Outcome Measure Information:
Title
Verbal rating scale (VRS) pain scores after positioning the patient to performing the spinal anaesthesia.
Description
Independent blinded observer will assess the patient in the first 30 minutes, in every 5 minute. Sensory perception will be assess by using cold spray in the area of the terminal branch of femoral nerve. We will assess the pain on passive movement of the limb (elevating 30 degree) using verbal rating scale (VRS) pain score 1-10. When the patient reports less than 4 at the VRS the patient will be positioned for spinal anaesthesia. If the threshold isn't achieved by 30 minutes, the block will be classified as failure. Additional opioid medication and/or sedation will be administered.
Time Frame
The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.
Secondary Outcome Measure Information:
Title
Sensory distribution of the nerve block.
Description
An independent blinded observer (not present during block placement) will assess in the first 30 minutes (at 5 minute intervales) the sensory nerve block using a modified Bromage score. Sensory perception will be assessed using cold (ethyl chloride spray) in the area of the vastus medialis, vastus intermedius, vastus lateralis and saphenous nerve innervation area (terminal branch of femoral nerve).
Time Frame
The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block.
Title
Number of needle passes
Description
The Anaesthestist who performing the femoral nerve block was asked how many needle passes needed for the femoral nerve block.
Time Frame
during performing the femoral nerve block
Title
Femoral nerve block onset time
Description
We will assess the pain on passive movement of the limb (elevating 30 degree from the initial positioning) using verbal rating scale (VRS) pain score 1-10. When the patient reports less than 4 at the VRS the sensory block will be deemed adequate and the patient will be positioned on the side for spinal anaesthesia.
Time Frame
In the first 30 minutes after the femoral nerve block
Title
Patient satisfaction
Description
After the surgery during the recovery time, we will ask the patients regarding there Satisfaction, will be used visual analog scale 0-100 mm for measurement.
Time Frame
After the surgery in the recovery area before the patient will be discharged to the ward.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fractured neck of femur surgical fixation performed under spinal anaesthesia ASA I to III Exclusion Criteria: Patient refusal Coagulation disorders Head injury or other associated injuries Previous vascular surgery in the femoral area. Loss of consciousness and signs of acute coronary syndrome Mini-Mental Score < 25 (see appendix 3) Allergy to lignocaine, Skin lesions/infection at site of injection Sepsis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Szilard Szucs, MD
Organizational Affiliation
Cork University Hospital, Ireland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Hospital
City
Cork
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24460975
Citation
Szucs S, Morau D, Sultan SF, Iohom G, Shorten G. A comparison of three techniques (local anesthetic deposited circumferential to vs. above vs. below the nerve) for ultrasound guided femoral nerve block. BMC Anesthesiol. 2014 Jan 25;14:6. doi: 10.1186/1471-2253-14-6.
Results Reference
derived

Learn more about this trial

Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Hip Surgery

We'll reach out to this number within 24 hrs