MIDCAB (Mid-Calf Block) for Foot Surgery

Foot Surgery Clinical Trial

— MIDCAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368012
• Other study ID #: 2022-0066
• Status: Completed
• Phase: Phase 4
• Start date: July 21, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: September 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Surgery
• Foot Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Motor Function of Foot and Ankle Post-Operatively	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.	Measured in the PACU (post-anesthesia care unit) immediately upon patients arrival into the PACU.
Secondary	Opioid Use	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.	PACU, POD1 (1 day), POD2 (2 days) & POD7 (1 week)
Secondary	Presence of Paresthesia (Numbness)	Patients will be asked if they have any residual numbness in the foot or toes where the surgery took place.	POD 7 (1 week post-surgical discharge)
Secondary	Presence of Skin Irritation and Wounds	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.	POD 7 (1 week post-surgical discharge)
Secondary	Nausea & Vomiting	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	PACU, POD1 (1 day), POD2 (2 days) & POD7 (1 week)