Dose Finding Study for Continuous Spinal Anaesthesia

NCT01680120 | Unknown Phase 4

• 2 other identifiers: CUH07/03/2012ECM 4 (ii) 10/01/12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Femoral Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• MLAD/ vertebral length

  In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed

• Pain experienced by the patients in the operating theatre.

  In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed

• Patient satisfaction after surgery regarding pain relief.

  In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed

• 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

• 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

Study Arms (1)

Continuous spinal anaesthesia

EXPERIMENTAL

Procedure: Continuous spinal anaesthesia

Interventions

Continuous spinal anaesthesia PROCEDURE

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).

Continuous spinal anaesthesia

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 60 years
• ASA I to III patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

Cork University Hospital

Cork, Cork, Ireland

Location

Related Publications (9)

• 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.

  PMID: 15220175 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.

  PMID: 16632842 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.

  PMID: 15516345 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.

  PMID: 19512869 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.

  PMID: 17478453 BACKGROUND

• 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. doi: 10.1111/j.1365-2044.2005.04442.x.

  PMID: 16480346 BACKGROUND

• 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.

  PMID: 12488372 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.

  PMID: 2007099 BACKGROUND

• Szucs S, Rauf J, Iohom G, Shorten GD. Determination of the minimum initial intrathecal dose of isobaric 0.5% bupivacaine for the surgical repair of a proximal femoral fracture: A prospective, observational trial. Eur J Anaesthesiol. 2015 Nov;32(11):759-63. doi: 10.1097/EJA.0000000000000235.

  PMID: 25693137 DERIVED

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Szilard Szucs, MD

  Cork University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Szilard Szucs, MD

CONTACT

00353872730724; szilard.szucs@yahoo.ie

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Tutor in Anaesthesia

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: September 6, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 6, 2012

Record last verified: 2012-09

Locations

IE (1)