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NCT Number: NCT05368012

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 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.

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Key information

Conditions

Ankle Surgery Foot Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIDCAB

Drug

Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.

Other names: Bupivacaine and dexamethasone

Primary outcomes

  1. Block Duration

    Time frame: Out to 1 week postoperatively

    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 measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to state the specific time-points they began to have pain after surgery.

Secondary outcomes

  1. Number of Participants With Return of Motor Function of Foot and Ankle Post-Operatively

    Time frame: Measured in the PACU (post-anesthesia care unit) immediately upon patients arrival into the PACU, up to 1 hour after surgery.

    The return of the patient's foot/ankle motor function which will be measured by whether the patient can dorsiflex/plantarflex at the ankle or have flexion/extension of the toes.

  2. Cumulative Opioid Consumption

    Time frame: 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)

    Cumulative opioid consumption in morphine equivalents will be recorded post surgical discharge (in PACU), 24h post surgical discharge, 48 hours post surgical discharge, and 1 week post surgical discharge.

  3. Presence of Paresthesia (Numbness)

    Time frame: POD 7 (1 week post-surgical discharge)

    Patients will be asked if they have any residual numbness in the foot or toes where the surgery took place.

  4. Presence of Skin Irritation and Wounds

    Time frame: POD 7 (1 week post-surgical discharge)

    Patients will be asked if they have any wounds or irritation to the skin (i.e. rashes, itching, burning, etc.) on the skin at the site of surgery and/or site of the block.

  5. Presence of Nausea

    Time frame: 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)

    The questionnaire used asks patients if they have experienced any nausea.

  6. Severity of Nausea

    Time frame: 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)

    Patients are asked on a scale from 0-10 (0 being not severe and 10 being the worst severity) how severe their nausea was. This will be measured post surgical discharge (in PACU), 24h post surgical discharge, 48 hours post surgical discharge, and 1 week post surgical discharge

  7. Number of Total Episodes of Nausea

    Time frame: 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)

    Patients were asked how many episodes of nausea had occurred.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

MIDCAB (Mid-Calf Block) for Foot Surgery: A Pilot Study

Acronym: MIDCAB

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 10, 2022
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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