NCT02383615

Brief Summary

Saphenous nerve blocks can be technically challenging. Recently described ultrasound techniques have improved the success rate of saphenous nerve blocks, but randomized controlled trials comparing these techniques are lacking. The investigators compared two common ultrasound guided approach for saphenous nerve block: saphenous nerve block at the adductor canal (ACSNB) vs. block by the distal trans-sartorial (DTSNB) approach.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

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

April 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

February 24, 2015

Last Update Submit

March 2, 2015

Conditions

Efficacy of Ultrasound Guided Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Success rate of the saphenous nerve block

    Loss of pin prick sensation to 2 of the 3 pre-defined areas of saphenous nerve distribution in the operative leg after performing the nerve block.

    30 minutes

Secondary Outcomes (3)

  • Speed of onset of saphenous nerve block

    30 minutes

  • Nerve visibility under ultrasound

    30 minutes

  • Time taken to perform block

    30 minutes

Study Arms (2)

DTSNB

ACTIVE COMPARATOR

Distal transsartorial saphenous nerve block

Procedure: Saphenous nerve block

ACSNB

ACTIVE COMPARATOR

Adductor canal saphenous nerve block

Procedure: Saphenous nerve block

Interventions

Saphenous nerve blockPROCEDURE

Ultrasound guided saphenous nerve blocks with 0.5% Ropivacaine for patients undergoing elective foot and ankle surgery for post-operative pain relief.

ACSNBDTSNB

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective foot and ankle surgery receiving saphenous nerve block for pain management
  • American Society of Anesthesiologists Physical Status (ASA PS) scores 1, 2 and 3

You may not qualify if:

  • Neuropathy
  • Allergy to local anesthetics
  • ASA PS scores 4 and 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 9, 2015

Study Start

April 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 9, 2015

Record last verified: 2015-03