Trial Outcomes & Findings for MIDCAB (Mid-Calf Block) for Foot Surgery (NCT NCT05368012)
NCT ID: NCT05368012
Last Updated: 2025-04-15
Results Overview
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.
COMPLETED
PHASE4
20 participants
Out to 1 week postoperatively
2025-04-15
Participant Flow
Participant milestones
| Measure |
Treatment
A total of 20 patients will be enrolled and will receive the stand of care analgesic protocol in addition to the following MIDCAB nerve block. There is only one treatment group in this study, no placebo group. The rationale behind there being one group is that this is a small pilot study that intends to inform subsequent randomized clinical control trials.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MIDCAB (Mid-Calf Block) for Foot Surgery
Baseline characteristics by cohort
| Measure |
Active MIDCAB
n=20 Participants
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.
|
|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Out to 1 week postoperativelyThe 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.
Outcome measures
| Measure |
Active MIDCAB
n=20 Participants
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.
|
|---|---|
|
Block Duration
|
18.2 hours
Interval 4.5 to 24.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active MIDCAB
n=20 Participants
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.
|
|---|---|
|
Number of Participants With Return of Motor Function of Foot and Ankle Post-Operatively
|
20 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active MIDCAB
n=20 Participants
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.
|
|---|---|
|
Cumulative Opioid Consumption
PACU
|
0 mg oral morphine equivalents
Interval 0.0 to 7.5
|
|
Cumulative Opioid Consumption
POD1
|
15 mg oral morphine equivalents
Interval 0.0 to 33.8
|
|
Cumulative Opioid Consumption
POD2
|
8.8 mg oral morphine equivalents
Interval 3.8 to 27.0
|
|
Cumulative Opioid Consumption
POD7
|
30 mg oral morphine equivalents
Interval 7.5 to 67.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active MIDCAB
n=20 Participants
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.
|
|---|---|
|
Presence of Paresthesia (Numbness)
|
5 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active MIDCAB
n=20 Participants
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.
|
|---|---|
|
Presence of Skin Irritation and Wounds
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active MIDCAB
n=20 Participants
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.
|
|---|---|
|
Presence of Nausea
POD1
|
2 Participants
|
|
Presence of Nausea
POD2
|
3 Participants
|
|
Presence of Nausea
POD7
|
2 Participants
|
|
Presence of Nausea
PACU
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Active MIDCAB
n=20 Participants
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.
|
|---|---|
|
Severity of Nausea
PACU
|
3 Scores on a scale
Interval 3.0 to 3.0
|
|
Severity of Nausea
POD1
|
6.5 Scores on a scale
Interval 6.0 to 7.0
|
|
Severity of Nausea
POD2
|
3.67 Scores on a scale
Interval 2.0 to 5.0
|
|
Severity of Nausea
POD7
|
3 Scores on a scale
Interval 3.0 to 3.0
|
SECONDARY outcome
Timeframe: 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.
Patients were asked how many episodes of nausea had occurred.
Outcome measures
| Measure |
Active MIDCAB
n=20 Participants
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.
|
|---|---|
|
Number of Total Episodes of Nausea
PACU
|
1 episodes
Interval 1.0 to 1.0
|
|
Number of Total Episodes of Nausea
POD1
|
2 episodes
Interval 1.0 to 3.0
|
|
Number of Total Episodes of Nausea
POD2
|
1.33 episodes
Interval 1.0 to 2.0
|
|
Number of Total Episodes of Nausea
POD7
|
1.5 episodes
Interval 1.0 to 2.0
|
Adverse Events
Active MIDCAB
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
MIDCAB (Mid-Calf Block) for foot surgery: A pilot study
Hospital for Special Surgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place