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NCT05368012 · ClinicalTrials.gov registry record · Phase 4
MIDCAB (Mid-Calf Block) for Foot Surgery
A Phase 4 study of Ankle Surgery and Foot Surgery, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05368012: Completed Phase 4 study of Ankle Surgery and Foot Surgery, sponsored by Hospital for Special Surgery, New York.
NCT05368012 is a Phase 4 study of Ankle Surgery and Foot Surgery that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05368012, a Phase 4 study of Ankle Surgery and Foot Surgery, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 foot/ankle 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 foot/ankle 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.
Primary Outcome
The primary outcome will be block duration, how long the MIDCAB block provides analgesia. This will be measured via questionnaires of pain scores given to patients post surgical discharge (in PACU), 24h post surgical discharge, 48 hours post surgical discharge, and 1 week post surgical discharge. This will be done by measuring the change in patient's pains scores over the course of 7 days. Pain scores will be measured via NRS pain scale; the NRS (numeric rating scale) is a questionnaire that mea
Conditions Studied
Interventions
- DRUG MIDCAB
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-07-21 |
| Est. Completion | 2022-11-29 |
| Phase | Phase 4 |
What the finished NCT05368012 record still lists
NCT05368012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Ankle Surgery appearing as the primary indexed condition, and to 1 intervention - of which MIDCAB is the first listed.
NCT05368012 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05368012 about?
NCT05368012 is a clinical study titled "MIDCAB (Mid-Calf Block) for Foot Surgery". 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...
What is the current status of trial NCT05368012?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2022-07-21. Estimated completion is 2022-11-29.
What conditions does trial NCT05368012 study?
This clinical trial studies the following conditions: Ankle Surgery, Foot Surgery.
What interventions are being tested in trial NCT05368012?
The interventions under investigation include: MIDCAB (DRUG).
Who is sponsoring clinical trial NCT05368012?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05368012 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05368012's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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