NCT02302378

Brief Summary

Spinal anesthesia is a common technique for providing anesthesia for knee joint replacement surgery. The investigators wish to demonstrate that using a lower approach to spinal anesthetic (Taylor's approach of L5-S1) causes less low blood pressure while still providing adequate anesthesia for knee joint replacement surgery than a higher approach (L3-L4).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

November 20, 2014

Last Update Submit

December 2, 2015

Conditions

Spinal Anesthesia

Keywords

HypotensionAnesthesia, Spinal [E03.155.086.331]

Outcome Measures

Primary Outcomes (1)

  • Hypotension

    Level of decrease in Blood Pressure following administration of spinal anesthetic

    For duration of total knee joint replacement, an expected average of 1 hour

Secondary Outcomes (3)

  • Time taken for technique

    For duration of spinal anesthetic procedure, an expected duration of 5 minutes

  • Patient acceptability of technique

    For duration of spinal anesthetic procedure, an expected duration of 5 minutes

  • Success of central neuraxial blockade

    30 minutes

Study Arms (2)

Taylor's approach

ACTIVE COMPARATOR

This arm will have the procedure of spinal anesthetic performed via 'Taylor's approach' which is a paramedian approach to interspace L5 - S1. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours.

Procedure: Taylor's approach (paramedian approach at L5-S1 interspace)

Lumbar approach

ACTIVE COMPARATOR

This arm will have the procedure of spinal anesthetic performed via a paramedian 'Lumbar approach' at interspace L3-L4. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours.

Procedure: Lumbar paramedian approach at L3-L4 interspace

Interventions

Lumbar paramedian approach at L3-L4 interspacePROCEDURE

Spinal anesthesia will be performed via a lumbar paramedian approach at L3-L4 interspace using 12.5mg 0.5% Bupivacaine (preservative free)

Also known as: 12.5mg 0.5% Bupivacaine (preservative free)
Lumbar approach
Taylor's approach (paramedian approach at L5-S1 interspace)PROCEDURE

Spinal anesthesia will be performed via Taylor's approach (paramedian approach at L5-61 interspace) using 12.5mg 0.5% Bupivacaine (preservative free)

Also known as: 12.5mg 0.5% Bupivacaine (preservative free)
Taylor's approach

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand study protocol and give informed consent
  • Presenting for primary total knee joint arthroplasty at University of British Columbia Hospital
  • American Society of Anesthesiology (ASA) Class 1, 2 or 3

You may not qualify if:

  • American Society of Anesthesiology (ASA) Class 4 or 45
  • Patients who have elected not to have spinal anesthesia for their procedure
  • Patients deemed clinically inappropriate for spinal anesthesia by the attending anesthesiologist
  • Patients who are allergic to Local Anesthetic or Ultrasound gel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia Department of Anesthesiology, Pharmacology and Therapeutics

Vancouver, British Columbia, V6Z 1L8, Canada

Location

Related Publications (10)

  • Taylor JA. Lumbosacral subarachnoid tap. J Urol 1940;43:561

    BACKGROUND

  • Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.

    PMID: 1599111BACKGROUND

  • Chin KW, Chin NM, Chin MK. Spread of spinal anaesthesia with 0.5% bupivacaine: influence of the vertebral interspace and speed of injection. Med J Malaysia. 1994 Jun;49(2):142-8.

    PMID: 8090093BACKGROUND

  • Lowson SM, Brown J, Wilkins CJ. Influence of the lumbar interspace chosen for injection on the spread of hyperbaric 0.5% bupivacaine. Br J Anaesth. 1991 Apr;66(4):465-8. doi: 10.1093/bja/66.4.465.

    PMID: 2025473BACKGROUND

  • Saric JP, Mikulandra S, Gustin D, Matasic H, Tomulic K, Dokoza KP. Spinal anesthesia at the L2-3 and L3-4 levels: comparison of analgesia and hemodynamic response. Coll Antropol. 2012 Mar;36(1):151-6.

    PMID: 22816213BACKGROUND

  • Furness G, Reilly MP, Kuchi S. An evaluation of ultrasound imaging for identification of lumbar intervertebral level. Anaesthesia. 2002 Mar;57(3):277-80. doi: 10.1046/j.1365-2044.2002.2403_4.x.

    PMID: 11892638BACKGROUND

  • Watson MJ, Evans S, Thorp JM. Could ultrasonography be used by an anaesthetist to identify a specified lumbar interspace before spinal anaesthesia? Br J Anaesth. 2003 Apr;90(4):509-11. doi: 10.1093/bja/aeg096.

    PMID: 12644427BACKGROUND

  • Halpern SH, Banerjee A, Stocche R, Glanc P. The use of ultrasound for lumbar spinous process identification: A pilot study. Can J Anaesth. 2010 Sep;57(9):817-22. doi: 10.1007/s12630-010-9337-x. Epub 2010 May 25.

    PMID: 20499222BACKGROUND

  • Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.

    PMID: 21572316BACKGROUND

  • Perlas A. Evidence for the use of ultrasound in neuraxial blocks. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S43-6. doi: 10.1097/AAP.0b013e3181d2462e.

    PMID: 20216024BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Himat Vaghadia, MBBS

    Clinical Anesthesiologist, University of British Columbia Department of Anesthesiology, Pharmacology and Therapeutics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 27, 2014

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

CA(1)