- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01922622
Minimum Effective Intrathecal Dose of Local Anaesthetic With Fentanyl for Fractured Neck of Femur(Dose Finding Study).
Determination of the Initial Minimum Effective Dose of 0.5% Bupivacaine With 20mcg of Fentanyl Via a Spinal Catheter for Operative Fixation of Fractured Neck of Femur.
Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients with multiple comorbidities. Anaesthetic management of this patient group is extremely challenging.Neuraxial anaesthesia with minimum doses of local anaesthetic agents administered via a spinal catheter leads to better cardiovascular stability.The minimum dose of local anaesthetic with intrathecal fentanyl was not established yet.We propose to study and determine the initial minimum local anaesthetic dose (MLAD) of 0.5% bupivacaine with 20 mcg of fentanyl administered via a spinal catheter to achieve a sensory block up to T10 for the operative fixation of FNF.We will use a previously well established Dixon and Massey "up-and-down method" to calculate initial MLAD in this prospective, observational trial.
Objectives: We would like to determine the initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl administered via a spinal catheter required to achieve a sensory block up to T10 on the side of FNF.
Outcomes
Primary outcome:
Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF.
Secondary outcomes:
- Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur.
- The effect on haemodynamic variables (blood pressure, heart rate).
- Incidence of side effects
- The length of postoperative analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS>3).
- The time to first rescue analgesic requirement
Study Design Prospective, observational trial.
Study Size Based on the previously well established Dixon and Massey "up-and-down method"(10), we will recruit patients until a successful spinal block has been achieved in six consecutive patients who received a specific dose. This is the requirement to calculate the initial MLAD.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cork, Ireland, 00000
- Cork University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- fractured neck of femur
- Above 60 years
- American Society of Anesthetists(ASA) I to III
Exclusion Criteria:
- Patient refusal
- Outside Age Range
- Contraindications to spinal anaesthesia
- Head injury or other associated injuries
- Loss of consciousness and signs of acute coronary syndrome
- Mini-Mental Score < 25 (Appendix 2)
- Allergy to bupivacaine, lignocaine or fentanyl
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Bipolar hemiarthroplasty.
Group of patients who will stay in lateral position during whole surgery.
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Dynamic hip screw.
Group of patients who will be supine during surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF
Time Frame: 15min
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A blinded observer will assess the dermatome level of sensory blockade with an ice-cold test (ethyl-chloride spray) bilaterally after the injection of the local anaesthetic.
Block assessment will be performed every 5min up to 15 min after completion of the initial intrathecal injection.
Sensory block up to T10=positive result Sensory block below T10=negative result.
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15min
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur
Time Frame: Duration of surgery.
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Initial dose and all top ups will be recorded and analysed in conjunction with the length of surgery and surgical procedure used to fix FNF.
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Duration of surgery.
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The effect on haemodynamic variables (blood pressure, heart rate).
Time Frame: Duration of surgery.
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Noninvasive automated blood pressure and heart rate measurements will be recorded before the spinal anaesthesia (baseline) and every three minutes after the end of local anesthetic injection until the end of surgery.Hypotension is defined as a decrease of more than 20% from the baseline systolic arterial blood pressure (SAP).
Severe hypotension is defined as a decrease in SAP more than 30% of baseline value.
Hypotension will be treated with IV boluses of ephedrine 6 mg if the heart rate is below 60/minutes or phenylephrine 100 mcg if the heart rate is above 60/minutes.The number of hypotensive episodes, a total amount of vasopressor administered, and the i.v.
fluid infused will be recorded as well as duration of anaesthesia.
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Duration of surgery.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of side effects.
Time Frame: 24-48 hours
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Patients will be interviewed 24-48 hours after surgery regarding side effects of spinal anaesthesia (headache, pruritus,postoperative nausea and vomiting,urinary retention,neurological deficit)
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24-48 hours
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The length of postoperative analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS>3).
Time Frame: 1-2 hours
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The time from the last top up of local anaesthetic to VAS >3 and to the first dose of break through analgesia will be recorded.
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1-2 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tomas Hitka, RA fellow, Cork University Hospital
- Study Chair: Gabriella Iohom, consultant, Cork University Hospital
Publications and helpful links
General Publications
- Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. doi: 10.1093/bja/aem100. Epub 2007 May 3.
- Stocks GM, Hallworth SP, Fernando R, England AJ, Columb MO, Lyons G. Minimum local analgesic dose of intrathecal bupivacaine in labor and the effect of intrathecal fentanyl. Anesthesiology. 2001 Apr;94(4):593-8; discussion 5A. doi: 10.1097/00000542-200104000-00011.
- Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25. No abstract available.
- Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.
- Sell A, Olkkola KT, Jalonen J, Aantaa R. Minimum effective local anaesthetic dose of isobaric levobupivacaine and ropivacaine administered via a spinal catheter for hip replacement surgery. Br J Anaesth. 2005 Feb;94(2):239-42. doi: 10.1093/bja/aei015. Epub 2004 Oct 29.
- O'Donnell BD, Iohom G. An estimation of the minimum effective anesthetic volume of 2% lidocaine in ultrasound-guided axillary brachial plexus block. Anesthesiology. 2009 Jul;111(1):25-9. doi: 10.1097/ALN.0b013e3181a915c7.
- Hartwell BL, Aglio LS, Hauch MA, Datta S. Vertebral column length and spread of hyperbaric subarachnoid bupivacaine in the term parturient. Reg Anesth. 1991 Jan-Feb;16(1):17-9.
- Idowu OA, Sanusi AA, Eyelade OR. Effects of intrathecally administered fentanyl on duration of analgesia in patients undergoing spinal anaesthesia for elective caesarean section. Afr J Med Med Sci. 2011 Sep;40(3):213-9.
- Egan TD, Kern SE, Muir KT, White J. Remifentanil by bolus injection: a safety, pharmacokinetic, pharmacodynamic, and age effect investigation in human volunteers. Br J Anaesth. 2004 Mar;92(3):335-43. doi: 10.1093/bja/aeh075.
- Machata AM, Gonano C, Holzer A, Andel D, Spiss CK, Zimpfer M, Illievich UM. Awake nasotracheal fiberoptic intubation: patient comfort, intubating conditions, and hemodynamic stability during conscious sedation with remifentanil. Anesth Analg. 2003 Sep;97(3):904-908. doi: 10.1213/01.ANE.0000074089.39416.F1.
- Hitka T, O'Sullivan J, Szucs S, Iohom G. Determination of the initial minimum effective dose of 0.5% bupivacaine with 20 mug of fentanyl for an operative fixation of fractured neck of femur: a prospective, observational trial. Minerva Anestesiol. 2021 Jul;87(7):766-773. doi: 10.23736/S0375-9393.21.15012-6. Epub 2021 Feb 16.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECM 4(qqqq)07/05/13
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