Minimum Effective Intrathecal Dose of Local Anaesthetic With Fentanyl for Fractured Neck of Femur(Dose Finding Study).
NCT ID: NCT01922622
Last Updated: 2015-02-04
Study Results
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Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2013-07-31
2014-06-30
Brief Summary
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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:
1. 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:
2. Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur.
3. The effect on haemodynamic variables (blood pressure, heart rate).
4. Incidence of side effects
5. The length of postoperative analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS\>3).
6. 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bipolar hemiarthroplasty.
Group of patients who will stay in lateral position during whole surgery.
No interventions assigned to this group
Dynamic hip screw.
Group of patients who will be supine during surgery.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Above 60 years
* American Society of Anesthetists(ASA) I to III
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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Cork University Hospital
OTHER
Responsible Party
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tomas hitka
Clinical fellow in Regional Anaesthesia
Principal Investigators
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Tomas Hitka, RA fellow
Role: PRINCIPAL_INVESTIGATOR
Cork University Hospital
Gabriella Iohom, consultant
Role: STUDY_CHAIR
Cork University Hospital
Locations
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Cork University Hospital
Cork, Cork, Ireland
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ECM 4(qqqq)07/05/13
Identifier Type: -
Identifier Source: org_study_id
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