MIDCAB (Mid-Calf Block) for Foot Surgery

NCT ID: NCT05368012

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-21
• Study Completion Date: 2022-11-29

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.

Conditions

Ankle Surgery; Foot Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

MIDCAB

Intervention Type: DRUG

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

Interventions

MIDCAB

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

Intervention Type: DRUG

Other Intervention Names

Bupivacaine and dexamethasone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrique Goytizolo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2022-0066

Identifier Type: -

Identifier Source: org_study_id