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Dose Finding Study for Continuous Spinal Anaesthesia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Szilard Szucs, Cork University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680120
First Posted: September 6, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Szilard Szucs, Cork University Hospital
  Purpose

Fixation of fractured neck of femur is a common Orthopedic surgery. Anaesthesia can be challenging in some cases like in haemodynamical unstable patients.

The investigators have evidence of minimum effective local anaesthetic dose (MLAD) in hip replacement surgery but MLAD to achieve surgical anaesthesia for operative fixation of FNF is still unknown.

A step-up/step-down methodology was used successfully in regional anaesthesia and also in other areas of anaesthesia.

In pregnant ladies in whom spinal anaesthesia is performed on the side, significant correlation exist between the vertebral length measured from cervical 7 to the iliac creast and MLAD.

The investigators aim it was to determine the MLAD of hyperbaric 0.5% bupivacaine required for Continuous spinal anaesthesia for the operative fixation of FNF.


Condition Intervention Phase
Femoral Fracture Procedure: Continuous spinal anaesthesia Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of the Minimum Local Anaesthetic Needed for Operative Fixation of Fractured Neck of Femur With Continuous Spinal Anaesthesia

Resource links provided by NLM:


Further study details as provided by Szilard Szucs, Cork University Hospital:

Primary Outcome Measures:
  • MLAD of 0.5 % bupivacaine for operative fixation of fractured neck of femur patients [ Time Frame: In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed ]
    Subarachnoid puncture will be performed with a 18-gauge Tuohy needle at the L4-5 or L3-4 interspace using a midline approach. Three cm of a 22-gauge catheter will be introduced cephalad through the needle. The initial dose is arbitrarily chosen as 1 ml of 0.5 % isobaric bupivacaine on the basis of clinical experience, the local anaesthetic will be injected through the catheter over 5-10 s.


Secondary Outcome Measures:
  • MLAD/ vertebral length [ Time Frame: In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed ]
  • Pain experienced by the patients in the operating theatre. [ Time Frame: In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed ]
  • Patient satisfaction after surgery regarding pain relief. [ Time Frame: In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed ]
  • Difference (if any) in effect on haemodynamic variables (i.e. heart rate and blood pressure). [ Time Frame: After performing spinal anaesthesia the blood pressure will be measured in every three minutes, ECG and pulse oximetry will me recorded continuously ]
  • Side effects of medication [ Time Frame: After performing spinal anaesthesia the blood pressure will be measured in every three minutes, ECG and pulse oximetry will me recorded continuously ]

Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous spinal anaesthesia Procedure: Continuous spinal anaesthesia

Standard monitoring including continuous electrocardiogram, noninvasive automated arterial blood pressure and pulse oximetry will be applied.

Subarachnoid puncture will be performed with a 18-gauge Tuohy needle at the L4-5 or L3-4 interspace using a midline approach. Three cm of a 22-gauge catheter will be introduced cephalad through the needle. The initial dose is arbitrarily chosen as 1 ml of 0.5 % isobaric bupivacaine on the basis of clinical experience, the local anaesthetic will be injected through the catheter over 5-10 s. After completion of injection the patients remain in the lateral position for 5 min and then will be returned to the supine position.

Successive injections of 0.2 ml of 0.5 % isobaric bupivacaine will be performed every 15 min until a satisfactory sensory level is obtained (T12).


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Above 60 years
  • ASA I to III patients

Exclusion Criteria:

  • Patient refusal
  • Outside Age Range
  • Coagulation disorders
  • Head injury or other associated injuries
  • Loss of consciousness and signs of acute coronary syndrome
  • Mini-Mental Score < 25
  • Allergy to bupivacaine, lignocaine
  • Skin lesions/infection at site of injection
  • Sepsis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680120


Contacts
Contact: Szilard Szucs, MD 00353872730724 szilard.szucs@yahoo.ie

Locations
Ireland
Cork University Hospital Not yet recruiting
Cork, Ireland
Contact: Szilard Szucs, MD    00353872730724    szilard.szucs@yahoo.ie   
Principal Investigator: Szilard Szucs, MD, PhD         
Sponsors and Collaborators
Cork University Hospital
Investigators
Principal Investigator: Szilard Szucs, MD Cork University Hospital, Ireland
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Szilard Szucs, Clinical Tutor in Anaesthesia, Cork University Hospital
ClinicalTrials.gov Identifier: NCT01680120     History of Changes
Other Study ID Numbers: CUH07/03/2012
ECM 4 (ii) 10/01/12 ( Registry Identifier: Clinical Research ethics Committee of the Cork Teaching Hospitals, Ireland )
First Submitted: March 7, 2012
First Posted: September 6, 2012
Last Update Posted: October 12, 2017
Last Verified: September 2012

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