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

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

Study Description

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

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Active MIDCAB; 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).	Drug: MIDCAB; Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.; Other Name: Bupivacaine and dexamethasone

Outcome Measures

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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Jessica Gjonaj, BA; 212.774.2678; gjonajj@hss.edu

Contact: Justas Lauzadis, PhD; 212.774.2946; lauzadisj@hss.edu

Locations

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

Investigators

• Principal Investigator: Enrique Goytizolo, MD; Hospital for Special Surgery, New York

More Information

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT05368012
• Other Study ID Numbers: 2022-0066
• First Posted: May 10, 2022
• 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.

• 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:

Dexamethasone; Bupivacaine; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents