Viewing Study NCT05368012



Ignite Creation Date: 2024-05-06 @ 5:35 PM
Last Modification Date: 2024-10-26 @ 2:32 PM
Study NCT ID: NCT05368012
Status: COMPLETED
Last Update Posted: 2023-09-28
First Post: 2022-03-29

Brief Title: MIDCAB Mid-Calf Block for Foot Surgery
Sponsor: Hospital for Special Surgery New York
Organization: Hospital for Special Surgery New York

Study Overview

Official Title: MIDCAB Mid-Calf Block for Foot Surgery A Pilot Study
Status: COMPLETED
Status Verified Date: 2023-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MIDCAB
Brief Summary: MIDCAB is defined as a group of ultrasound guided distal nerve blocks at the level of the individual branches It is similar to an Ultrasound Guided USG Ankle block but the probe is placed higher on the calf covering all and any surgery of the foot and ankle providing prolonged analgesia since we are blocking the individual nerves and preserving the proximal motor function

This study is determining the potential therapeutic effect of MIDCAB during the hospital stay and recovery period in patients undergoing footankle surgeries that require spinal anesthetic and peripheral nerve blocks A total of 20 patients at HSS will participate to see if MIDCAB is not only effective at providing analgesia pain relief but to see if it allows allows patients to maintain motor function movement of the foot and ankle unlike the current popliteal block which is done above the knee and prevents patients from moving their foot

During the course of the study we will also be looking at patients numeric pain scores with movement and at rest along with post-operative nausea and vomiting the presence of numbness and it patients can move their foot Along with all of these the study will also look at the amount of opioid pain medications taken by patients along with medication-related side effects As a result the study will be used to determine if MIDCAB provides analgesia for patients undergoing footankle surgery while allowing them to maintain movement of the foot This pilot study will also be used to gather preliminary data that will allow us to perform a power analysis for a subsequent randomized clinical control trial that would compare the MIDCAB block to the popliteal block
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None