MIDCAB (Mid-Calf Block) for Foot Surgery: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Block Duration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned use of regional anesthesia
- •Ability to follow the major components of the study protocol
- •Planned foot or angle surgery
排除标准
- •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
研究组 & 干预措施
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).
干预措施: MIDCAB (Drug)
结局指标
主要结局
Block Duration
时间窗: 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.
次要结局
- Presence of Paresthesia (Numbness)(POD 7 (1 week post-surgical discharge))
- 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 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))
- 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))
- 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))