Femoral Fracture Clinical Trial
Official title:
Determination of the Minimum Local Anaesthetic Needed for Operative Fixation of Fractured Neck of Femur With Continuous Spinal Anaesthesia
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.
Status | Unknown status |
Enrollment | 15 |
Est. completion date | December 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Ireland | Cork University Hospital | Cork |
Lead Sponsor | Collaborator |
---|---|
Cork University Hospital |
Ireland,
Burlacu CL, Gaskin P, Fernandes A, Carey M, Briggs L. A comparison of the insertion characteristics of the laryngeal tube and the laryngeal mask airway: a study of the ED50 propofol requirements. Anaesthesia. 2006 Mar;61(3):229-33. — View Citation
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. Epub 2007 May 3. — View Citation
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. — View Citation
Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. Epub 2004 Jun 25. Review. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2004 Oct 29. — View Citation
Tanaka M, Nishikawa T. Propofol requirement for insertion of cuffed oropharyngeal airway versus laryngeal mask airway with and without fentanyl: a dose-finding study. Br J Anaesth. 2003 Jan;90(1):14-20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MLAD of 0.5 % bupivacaine for operative fixation of fractured neck of femur patients | 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. | In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed | |
Secondary | MLAD/ vertebral length | In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed | ||
Secondary | Pain experienced by the patients in the operating theatre. | In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed | ||
Secondary | Patient satisfaction after surgery regarding pain relief. | In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed | ||
Secondary | Difference (if any) in effect on haemodynamic variables (i.e. heart rate and blood pressure). | After performing spinal anaesthesia the blood pressure will be measured in every three minutes, ECG and pulse oximetry will me recorded continuously | ||
Secondary | Side effects of medication | After performing spinal anaesthesia the blood pressure will be measured in every three minutes, ECG and pulse oximetry will me recorded continuously |
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