Pre-post Spinal Popliteal Block

April 29, 2024 updated by: Hospital for Special Surgery, New York

Comparison of Success and Injury (Neuropraxia) Rate When Performing the Sciatic Nerve Block in the Popliteal Fossa Pre vs. Post Spinal Anesthesia for Foot and Anke Procedures: Retrospective Review

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

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.

Primary outcome:

- The investiigators will be looking into persistent abnormal neuropathic symptoms lasting more than 7 days following a sciatic popliteal nerve block.

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • all other surgeries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent Abnormal Neuropathic Symptoms
Time Frame: lasting more than 7 days following a sciatic popliteal nerve block
Definition of abnormal neuropathic symptoms including numbness, tingling, burning, or pain sensation.
lasting more than 7 days following a sciatic popliteal nerve block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS pain scores in recovery
Time Frame: PACU recovery stay (up to 48 hours)
A score on a scale from 0 to 10 on how bad the pain is. 0 means no pain, 10 means worst pain. A lower score means a better outcome.
PACU recovery stay (up to 48 hours)
Amount of supplemental analgesic and antiemetic provided in the PACU
Time Frame: PACU recovery stay (up to 48 hours)
This includes: IV dilaudid push, oral oxycodone, tramadol, hydrocodone, dilaudid, acetaminophen, ketorolac, ondansetron, dexamethasone.
PACU recovery stay (up to 48 hours)
Anesthesia induction time
Time Frame: From the time which patients enter the OR to time of anesthesia induction end (up to 24 hours)
time from entering the OR to time of anesthesia induction end as defined by the completion of both the spinal and sciatic nerve blockade
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
Time Frame: during induction time (up to 24 hours)
during induction time (up to 24 hours)
Amount of sedation given
Time Frame: during induction time (up to 24 hours)
fentanyl, ketamine, midazolam, propofol
during induction time (up to 24 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Sang Kim, MD, Hospital for Special Surgery, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-1642

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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