NCT05354791

Brief Summary

This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart.

Trial Health

57
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Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

May 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

April 8, 2022

Last Update Submit

April 29, 2024

Conditions

Foot SurgeryAnkle Surgery

Keywords

lower extremity peripheral nerve blockspinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • Persistent Abnormal Neuropathic Symptoms

    Definition of abnormal neuropathic symptoms including numbness, tingling, burning, or pain sensation.

    lasting more than 7 days following a sciatic popliteal nerve block

Secondary Outcomes (5)

  • NRS pain scores in recovery

    PACU recovery stay (up to 48 hours)

  • Amount of supplemental analgesic and antiemetic provided in the PACU

    PACU recovery stay (up to 48 hours)

  • Anesthesia induction time

    From the time which patients enter the OR to time of anesthesia induction end (up to 24 hours)

  • Number of hypoxemia events during induction time

    during induction time (up to 24 hours)

  • Amount of sedation given

    during induction time (up to 24 hours)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators plan to analyze data for patients who underwent ambulatory foot or ankle procedures with the use of spinal anesthesia and sciatic nerve block in the popliteal fossa at HSS between March 1, 2016 and February 24, 2020

You may qualify if:

  • ambulatory foot surgery
  • ambulatory ankle surgery
  • use of spinal Anesthesia
  • use of pre-spinal anesthesia nerve block techniques
  • use of sciatic nerve block

You may not qualify if:

  • all other surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Study Officials

  • Sang Kim, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 29, 2022

Study Start

May 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

May 1, 2024

Record last verified: 2024-04

Locations

US(1)