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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Szilard Szucs, Cork University Hospital
ClinicalTrials.gov Identifier:
NCT01527812
First received: February 1, 2012
Last updated: March 31, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Fractured Neck of Femur
Procedure: Femoral nerve block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Operative Fixation of Fractured Neck of Femur

Resource links provided by NLM:


Further study details as provided by Cork University Hospital:

Primary Outcome Measures:
  • Verbal rating scale (VRS) pain scores after positioning the patient to performing the spinal anaesthesia. [ Time Frame: The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block. ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: The patient will be assessed in every five minutes up to 30 minutes after the femoral nerve block. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: during performing the femoral nerve block ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: In the first 30 minutes after the femoral nerve block ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: After the surgery in the recovery area before the patient will be discharged to the ward. ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Above the femoral nerve
In Group I we will inject the local anaesthetic below the fascia iliaca and above the femoral nerve.
Procedure: Femoral nerve block
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.
Experimental: Below the femoral nerve
In Group II we will inject the local anaesthetic below the femoral nerve and above the fascia of the iliopsoas muscle.
Procedure: Femoral nerve block
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.
Experimental: Circumferential
In Group III a circumferential spread will be achieved with multiple injections.
Procedure: Femoral nerve block
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.

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).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527812

Locations
Ireland
Cork University Hospital
Cork, Ireland
Sponsors and Collaborators
Cork University Hospital
Investigators
Principal Investigator: Szilard Szucs, MD Cork University Hospital, Ireland
  More Information

No publications provided

Responsible Party: Szilard Szucs, Clinical Tutor in Anaesthesia, Cork University Hospital
ClinicalTrials.gov Identifier: NCT01527812     History of Changes
Other Study ID Numbers: ECM 4 (zz) 08/12/09, ECM 4 (zz) 08/12/09
Study First Received: February 1, 2012
Last Updated: March 31, 2012
Health Authority: Ireland: Medical Ethics Research Committee

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014