Dose Finding Study for Continuous Spinal Anaesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Cork University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Szilard Szucs, Cork University Hospital
ClinicalTrials.gov Identifier:
NCT01680120
First received: March 7, 2012
Last updated: September 2, 2012
Last verified: September 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Patient satisfaction after surgery regarding pain relief. [ Time Frame: In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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
Study First Received: March 7, 2012
Last Updated: September 2, 2012
Health Authority: Ireland: Medical Ethics Research Committee

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

ClinicalTrials.gov processed this record on September 18, 2014