A Phase 4 interventional study of MIDCAB in Ankle Surgery and Foot Surgery, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Supportive care
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.
Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: Bupivacaine and dexamethasone
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.
Time frame: Out to 1 week postoperatively
Number of Participants With Return of 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.
Time frame: Measured in the PACU (post-anesthesia care unit) immediately upon patients arrival into the PACU, up to 1 hour after surgery.
Cumulative Opioid Consumption
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.
Time frame: 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)
Patients will be asked if they have any residual numbness in the foot or toes where the surgery took place.
Time frame: POD 7 (1 week post-surgical discharge)
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.
Time frame: POD 7 (1 week post-surgical discharge)
Presence of Nausea
The questionnaire used asks patients if they have experienced any nausea.
Time frame: 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)
Severity of Nausea
Patients are 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
Time frame: 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)
Number of Total Episodes of Nausea
Patients were asked how many episodes of nausea had occurred.
Time frame: 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)
| Milestone | Treatment |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| hours | Active MIDCAB |
|---|---|
| Block Duration | 18.2 (4.5 to 24.0) |
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.
| Participants | Active MIDCAB |
|---|---|
| Number of Participants With Return of Motor Function of Foot and Ankle Post-Operatively | 20 |
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.
| mg oral morphine equivalents | Active MIDCAB |
|---|---|
| PACU | 0 (0 to 7.5) |
| POD1 | 15 (0 to 33.8) |
| POD2 | 8.8 (3.8 to 27) |
| POD7 | 30 (7.5 to 67.5) |
Patients will be asked if they have any residual numbness in the foot or toes where the surgery took place.
| Participants | Active MIDCAB |
|---|---|
| Presence of Paresthesia (Numbness) | 5 |
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.
| Participants | Active MIDCAB |
|---|---|
| Presence of Skin Irritation and Wounds | 2 |
The questionnaire used asks patients if they have experienced any nausea.
| Participants | Active MIDCAB |
|---|---|
| PACU | 1 |
| POD1 | 2 |
| POD2 | 3 |
| POD7 | 2 |
Patients are 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
| Scores on a scale | Active MIDCAB |
|---|---|
| PACU | 3 (3 to 3) |
| POD1 | 6.5 (6 to 7) |
| POD2 | 3.67 (2 to 5) |
| POD7 | 3 (3 to 3) |
Patients were asked how many episodes of nausea had occurred.
| episodes | Active MIDCAB |
|---|---|
| PACU | 1 (1 to 1) |
| POD1 | 2 (1 to 3) |
| POD2 | 1.33 (1 to 2) |
| POD7 | 1.5 (1 to 2) |
Collected over Adverse Event Data was collected for 7 days post surgery. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active MIDCAB | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Active MIDCAB |
|---|---|
| Mean | 56.1 ± 13.3 |
| Sex: Female, Male(Participants) | Active MIDCAB |
|---|---|
| Female | 12 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Active MIDCAB |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Active MIDCAB |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Active MIDCAB |
|---|---|
| United States | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).
Supporting information: Study protocol
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital for Special Surgery, New York