MIDCAB (Mid-Calf Block) for Foot Surgery

NCT05368012 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2022-0066
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

foot and ankle surgery

Outcome Measures

Primary Outcomes (1)

• Block Duration

  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.

  Out to 1 week postoperatively

Secondary Outcomes (7)

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

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

• Cumulative Opioid Consumption

  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)

• Presence of Paresthesia (Numbness)

  POD 7 (1 week post-surgical discharge)

• Presence of Skin Irritation and Wounds

  POD 7 (1 week post-surgical discharge)

• Presence of Nausea

  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)

Study Arms (1)

Active MIDCAB

OTHER

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

Interventions

MIDCAB DRUG

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

Also known as: Bupivacaine and dexamethasone

Active MIDCAB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Bupivacaine; Dexamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: MIDCAB (Mid-Calf Block) for foot surgery: A pilot study
• Organization: Hospital for Special Surgery

popovicm@hss.edu

646-797-8948

Study Officials

• Enrique Goytizolo, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the active MIDCAB block.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: May 10, 2022
• Study Start: July 21, 2022
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)