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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bipolar hemiarthroplasty. | Group of patients who will stay in lateral position during whole surgery. | ||
| Dynamic hip screw. | Group of patients who will be supine during surgery. |
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| 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 | 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. | 15min |
| Measure | Description | Time Frame |
|---|---|---|
| Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur | 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. | Duration of surgery. |
| The effect on haemodynamic variables (blood pressure, heart rate). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of side effects. | 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) | 24-48 hours |
| The length of postoperative analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS>3). |
Inclusion Criteria:
Exclusion Criteria:
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patients with fractured neck of femur undergoing surgical repair of their fracture
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| Name | Affiliation | Role |
|---|---|---|
| Tomas Hitka, RA fellow | Cork University Hospital | Principal Investigator |
| Gabriella Iohom, consultant | Cork University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cork University Hospital | Cork | Cork | 00000 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15220175 | Background | 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. | |
| 16632842 | Background | 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. |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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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. |
| Duration of surgery. |
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. |
| 1-2 hours |
| 11379678 | Background | 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. |
| 22428515 | Background | 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. |
| 15516345 | Background | 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. |
| 19512869 | Background | 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. |
| 17478453 | Background | 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. |
| 2007099 | Background | 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. |
| 14970134 | Background | 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. |
| 12933427 | Background | 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. |
| 33591143 | Derived | 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. |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |