Ankle Surgery, Foot Surgery
Conditions
Keywords
foot and ankle surgery
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.
Interventions
DRUGMIDCAB
Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All participants will receive the active MIDCAB block.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Block Duration | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Presence of Paresthesia (Numbness) | 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. |
| Presence of Skin Irritation and Wounds | 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. |
| 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. | 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. |
| Severity 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) | 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 |
| Number of Total Episodes 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) | Patients were asked how many episodes of nausea had occurred. |
| 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) | The questionnaire used asks patients if they have experienced any nausea. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
MIDCAB: Ultrasound-guided administration of the nerve block MIDCAB into mid-calf as analgesic intervention for patients. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Active MIDCAB |
|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Out to 1 week postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active MIDCAB | Block Duration | 18.2 hours |
Secondary
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)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active MIDCAB | Cumulative Opioid Consumption | PACU | 0 mg oral morphine equivalents |
| Active MIDCAB | Cumulative Opioid Consumption | POD1 | 15 mg oral morphine equivalents |
| Active MIDCAB | Cumulative Opioid Consumption | POD2 | 8.8 mg oral morphine equivalents |
| Active MIDCAB | Cumulative Opioid Consumption | POD7 | 30 mg oral morphine equivalents |
Secondary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active MIDCAB | Number of Participants With Return of Motor Function of Foot and Ankle Post-Operatively | 20 Participants |
Secondary
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)
Population: The number analyzed is different than the overall number analyzed due to the fact that not every patient experienced any nausea. Only the patients who experienced nausea then got the follow up question about the severity of it.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active MIDCAB | Number of Total Episodes of Nausea | PACU | 1 episodes |
| Active MIDCAB | Number of Total Episodes of Nausea | POD1 | 2 episodes |
| Active MIDCAB | Number of Total Episodes of Nausea | POD2 | 1.33 episodes |
| Active MIDCAB | Number of Total Episodes of Nausea | POD7 | 1.5 episodes |
Secondary
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active MIDCAB | Presence of Nausea | POD7 | 2 Participants |
| Active MIDCAB | Presence of Nausea | POD2 | 3 Participants |
| Active MIDCAB | Presence of Nausea | PACU | 1 Participants |
| Active MIDCAB | Presence of Nausea | POD1 | 2 Participants |
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.
Time frame: POD 7 (1 week post-surgical discharge)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active MIDCAB | Presence of Paresthesia (Numbness) | 5 Participants |
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.
Time frame: POD 7 (1 week post-surgical discharge)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active MIDCAB | Presence of Skin Irritation and Wounds | 2 Participants |
Secondary
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)
Population: The number analyzed is different than the overall number analyzed due to the fact that not every patient experienced any nausea. Only the patients who experienced nausea then got the follow up question about the severity of it.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active MIDCAB | Severity of Nausea | PACU | 3 Scores on a scale |
| Active MIDCAB | Severity of Nausea | POD1 | 6.5 Scores on a scale |
| Active MIDCAB | Severity of Nausea | POD2 | 3.67 Scores on a scale |
| Active MIDCAB | Severity of Nausea | POD7 | 3 Scores on a scale |