NCT02589041

Brief Summary

This prospective, double-blinded study evaluates intraneural ropivacaine 1% Minimal Effective Volume (MEV90) for ultrasound-guided (US) popliteal sciatic nerve block, with Up-and-down methodology. To evaluate any neurological complications, an electrophysiological assessment will also be performed preoperatively and at 5 weeks after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

October 22, 2015

Last Update Submit

August 11, 2017

Conditions

US-guided Sciatic Nerve Block

Keywords

intraneural sciatic block

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the Intraneural Ropivacaine Minimal Effective Volume in 90% of patients (MEV90)

    6 months

Secondary Outcomes (1)

  • electrophysiological assessment of neurological deficit

    5 weeks

Study Arms (1)

Intraneural

EXPERIMENTAL

Using an Up-and-down methodology, the first patient receives 15 ml ropivacaine 1% intraneural injection. If unsuccessful, following patient will receive an increased dose of LA (2 ml). If successful, following patient will be randomized to have either the same LA dose (9 out of 10 probability) or 2 ml reduction of LA dose (1 out of 10 probability)

Procedure: intraneural sciatic nerve injectionDrug: Ropivacaine 1%

Interventions

intraneural sciatic nerve injectionPROCEDURE

A popliteal intraneural sciatic nerve block will be performed under ultrasound guidance. Minimal effective volume will be evaluated performing a randomization based on the Up-and-down methodology. A baseline and postoperative electrophysiological study will assess the presence of any neurological complication.

Intraneural
Ropivacaine 1%DRUG
Intraneural

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18 years old
  • ASA I-III
  • Signed informed consensus

You may not qualify if:

  • ASA IV
  • Unstable neurological disease
  • DM type I-II
  • Allergy to ropivacaine-mepivacaine
  • Opioid chronic treatment
  • Consensus refusal or not valid
  • Rheumatoid arthritis
  • Baseline electrophysiological study positive finding
  • Postoperative intensive care required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico G. Pini

Milan, Milano, 20122, Italy

Location

Study Officials

  • Gianluca Cappelleri, MD

    ASST Gaetano Pini-CTO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 28, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2016

Study Completion

April 1, 2017

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

IT(1)