Pre-post Spinal Popliteal Block

Foot Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05354791
• Other study ID #: 2019-1642
• Status: Terminated
• Start date: May 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1500
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Surgery
• Foot Surgery

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NRS pain scores in recovery	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)
Secondary	Amount of supplemental analgesic and antiemetic provided in the PACU	This includes: IV dilaudid push, oral oxycodone, tramadol, hydrocodone, dilaudid, acetaminophen, ketorolac, ondansetron, dexamethasone.	PACU recovery stay (up to 48 hours)
Secondary	Anesthesia induction time	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)
Secondary	Number of hypoxemia events during induction time		during induction time (up to 24 hours)
Secondary	Amount of sedation given	fentanyl, ketamine, midazolam, propofol	during induction time (up to 24 hours)