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MIDCAB (Mid-Calf Block) for Foot Surgery (MIDCAB)

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ClinicalTrials.gov Identifier: NCT05368012
Recruitment Status : Recruiting
First Posted : May 10, 2022
Last Update Posted : October 28, 2022
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Ankle Surgery Foot Surgery Drug: MIDCAB Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive the active MIDCAB block.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: MIDCAB (Mid-Calf Block) for Foot Surgery: A Pilot Study
Actual Study Start Date : July 21, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
Drug Information available for: Bupivacaine

Arm Intervention/treatment
USG with a 25G needle, Bupivacaine 0.5% 30ml with 4mg preservative free dexamethasone divided as follows into the following 5 nerves: Posterior Tibial nerve (10ml), Saphenous nerve (5ml), Deep peroneal Nerve (5ml), Superficial peroneal nerve (5 ml), and Sural Nerve (5ml).
Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.
Other Name: Bupivacaine and dexamethasone

Primary Outcome Measures :
  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 Outcome Measures :
  1. 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. ]
    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. Opioid Use [ Time Frame: PACU, POD1 (1 day), POD2 (2 days) & POD7 (1 week) ]
    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. Nausea & Vomiting [ Time Frame: PACU, POD1 (1 day), POD2 (2 days) & POD7 (1 week) ]
    The questionnaire used asks patients if they have experienced any nausea and vomiting, they are asked how many episodes of each have occurred. Patients are also 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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05368012

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Contact: Jessica Gjonaj, BA 212.774.2678 gjonajj@hss.edu
Contact: Justas Lauzadis, PhD 212.774.2946 lauzadisj@hss.edu

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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Justas Lauzadis, PhD    212-774-2946    lauzadisj@hss.edu   
Principal Investigator: Enrique Goytizolo, MD         
Sub-Investigator: Vincent LaSala, MD         
Sub-Investigator: Matthew Roberts, MD         
Sub-Investigator: Constantine Demetracopoulos, MD         
Sub-Investigator: Mark Drakos, MD         
Sub-Investigator: Jacques YaDeau, MD, PhD         
Sub-Investigator: Anne H Johnson, MD         
Sub-Investigator: Scott Ellis, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
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Principal Investigator: Enrique Goytizolo, MD Hospital for Special Surgery, New York
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT05368012    
Other Study ID Numbers: 2022-0066
First Posted: May 10, 2022    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: Investigators whose proposed use of the data has been approved by an Independent review committee ("learned intermediary") identified for this purpose and who have signed a DUA.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Hospital for Special Surgery, New York:
foot and ankle surgery
Additional relevant MeSH terms:
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Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents