NCT02382744

Brief Summary

Patients undergoing foot and ankle surgery have the option of having a nerve block administered by their Anesthesiologist. The nerve block numbs the foot and results in less post-operative nausea and vomiting, and better pain control. Two different techniques for blocking the saphenous nerve to the foot have been described and are both commonly used at St. Paul's hospital. The goal of this study is to compare the success rates of these two techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 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

Study Start

First participant enrolled

February 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 2, 2018

Completed
Last Updated

April 2, 2018

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

February 18, 2015

Results QC Date

July 26, 2016

Last Update Submit

September 6, 2017

Conditions

Saphenous Nerve Block

Keywords

Saphenous NerveNerve BlockUltrasound guidedNeurostimulationRegional AnesthesiaRopivacaineFoot SurgeryNerve StimulationAnkle Surgery

Outcome Measures

Primary Outcomes (1)

  • Block Success

    Complete absence of sensation to pinprick at two different anatomic areas of the saphenous nerve at thirty minutes

    30 minutes post nerve block

Secondary Outcomes (10)

  • Block Failure Rate

    30 minutes post nerve block

  • Any Evidence of Blockade (Decreased or Complete Absence of Sensation)

    30 min

  • Incomplete Block Rate

    30 minutes post nerve block

  • Speed of Onset for Nerve Block (Complete Blockade)

    30 minutes post nerve block

  • Rate of Success of Elicitation of a Tapping Sensation

    5 minutes

  • +5 more secondary outcomes

Study Arms (2)

Ultrasound Guidance

EXPERIMENTAL

Saphenous nerve block placed using ultrasound guidance alone

Device: Ultrasound Guidance

Ultrasound Guidance + nerve stimulation

EXPERIMENTAL

Saphenous nerve block placed using ultrasound guidance and nerve stimulation

Device: Ultrasound guidance + nerve stimulation

Interventions

Ultrasound GuidanceDEVICE

Ultrasound guidance will be used to place a saphenous nerve block

Ultrasound Guidance
Ultrasound guidance + nerve stimulationDEVICE

Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block

Ultrasound Guidance + nerve stimulation

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects undergoing foot and ankle surgery
  • Aged 19-80
  • Normal sensation in saphenous nerve distribution in both legs
  • Provided written informed consent.
  • Body Mass Index \<38 kg/m2

You may not qualify if:

  • Subject refusal
  • A known history of allergy, sensitivity or any other form of reaction to local anesthetics of amide type
  • Subjects on therapeutic anticoagulation or coagulopathy at the time of nerve blockade.
  • Participation in other clinical studies during this study or in the 14 days prior to admission to this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (10)

  • Tsui BC, Ozelsel T. Ultrasound-guided transsartorial perifemoral artery approach for saphenous nerve block. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):177-8; author reply 178. doi: 10.1097/AAP.0b013e31819a273e. No abstract available.

    PMID: 19282716BACKGROUND

  • Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.

    PMID: 19920424BACKGROUND

  • Lopez AM, Sala-Blanch X, Magaldi M, Poggio D, Asuncion J, Franco CD. Ultrasound-guided ankle block for forefoot surgery: the contribution of the saphenous nerve. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):554-7. doi: 10.1097/AAP.0b013e3182611483.

    PMID: 22854395BACKGROUND

  • Chen J, Lesser J, Hadzic A, Resta-Flarer F. The importance of the proximal saphenous nerve block for foot and ankle surgery. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):372. doi: 10.1097/AAP.0b013e318295596a. No abstract available.

    PMID: 23788076BACKGROUND

  • Head SJ, Leung RC, Hackman GP, Seib R, Rondi K, Schwarz SK. Ultrasound-guided saphenous nerve block--within versus distal to the adductor canal: a proof-of-principle randomized trial. Can J Anaesth. 2015 Jan;62(1):37-44. doi: 10.1007/s12630-014-0255-1. Epub 2014 Oct 22.

    PMID: 25337966BACKGROUND

  • Benzon HT, Sharma S, Calimaran A. Comparison of the different approaches to saphenous nerve block. Anesthesiology. 2005 Mar;102(3):633-8. doi: 10.1097/00000542-200503000-00023.

    PMID: 15731603BACKGROUND

  • Chi J, Greensmith JE. Saphenous nerve block technique with neurostimulation. Reg Anesth Pain Med. 2007 Nov-Dec;32(6):548-9. doi: 10.1016/j.rapm.2007.08.007. No abstract available.

    PMID: 18035315BACKGROUND

  • Comfort VK, Lang SA, Yip RW. Saphenous nerve anaesthesia--a nerve stimulator technique. Can J Anaesth. 1996 Aug;43(8):852-7. doi: 10.1007/BF03013038.

    PMID: 8840065BACKGROUND

  • van der Wal M, Lang SA, Yip RW. Transsartorial approach for saphenous nerve block. Can J Anaesth. 1993 Jun;40(6):542-6. doi: 10.1007/BF03009739.

    PMID: 8403121BACKGROUND

  • Montgomery SH, Shamji CM, Yi GS, Yarnold CH, Head SJ, Bell SC, Schwarz SK. Effect of Nerve Stimulation Use on the Success Rate of Ultrasound-Guided Subsartorial Saphenous Nerve Block: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):25-31. doi: 10.1097/AAP.0000000000000522.

    PMID: 27902645DERIVED

Results Point of Contact

Title
Dr. Stephan Schwarz, Director of Research
Organization
Department of Anesthesia, St. Paul's Hospital/Providence Health Care
stephan.schwarz@ubc.ca
(604) 806-8337

Study Officials

  • Scott Bell, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Scott Bell

Study Record Dates

First Submitted

February 18, 2015

First Posted

March 9, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 2, 2018

Results First Posted

April 2, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)