Clinical trial NCT05368012: MIDCAB (Mid-Calf Block) for Foot Surgery
Official title: MIDCAB (Mid-Calf Block) for Foot Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Surgery
Foot Surgery
Keywords: foot and ankle surgery
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the active MIDCAB block.
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility criteria: Inclusion Criteria:

* Planned use of regional anesthesia
* Ability to follow the major components of the study protocol
* Planned foot or angle surgery

Exclusion Criteria:

* Patients younger than 18 years old and older than 80 years old
* Patients intending to receive general anesthesia
* Contra-indication to nerve blocks or spinal anesthesia
* Patients with an ASA status of IV or higher
* Chronic opioid use (taking opioids for longer than 3 months)
* Patients with prior foot or ankle surgery
* Patients with type 2 diabetes

Primary outcomes:
measure: Block Duration
timeFrame: Out to 1 week postoperatively
Secondary outcomes:
measure: Number of Participants With Return of Motor Function of Foot and Ankle Post-Operatively
timeFrame: Measured in the PACU (post-anesthesia care unit) immediately upon patients arrival into the PACU, up to 1 hour after surgery.
measure: Cumulative Opioid Consumption
timeFrame: PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)
measure: Presence of Paresthesia (Numbness)
timeFrame: POD 7 (1 week post-surgical discharge)
measure: Presence of Skin Irritation and Wounds
timeFrame: POD 7 (1 week post-surgical discharge)
measure: Presence of Nausea
timeFrame: PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)
measure: Severity of Nausea
timeFrame: PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)
measure: Number of Total Episodes of Nausea
timeFrame: PACU (up until patients' discharge from the hospital), POD1 (Around 24 hrs after the PACU arrival time), POD2 (Around 48 hrs after the PACU arrival time) & POD7 (Around 1 week from the PACU arrival time)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Enrique Goytizolo, MD
role: PRINCIPAL_INVESTIGATOR
References: