A comparative study to evaluate the effectiveness of ultrasound-guided popliteal nerve block and a combination of ultrasound guided interfacial plane foot block with sural nerve block on postoperative analgesia in patients undergoing calcaneal surgery. A Randomized Controlied Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The times of rescue analgesia and the adverse reactions caused by the analgesics such as
研究概览
简要总结
Calcaneal fracture is a common foot and ankle injury and is associated with severe and difficult-to-manage pain. For patients with calcaneal fractures, surgery is generally the mainstay of treatment to relieve pain and correct foot dysfunction. Surgery can result in significant postoperative pain result in significant postoperative pain for at least 24 hours and if this postoperative pain is not managed well then it may lead to inactivity and possible complications like hematoma and wound dehiscence. The surgery is often done under spinal anesthesia, but its effect is limited and patients often complain of pain after a few hours.We hypothesized that the interfacial plane block and sural nerve combination may be like a popliteal nerve block for calcaneal surgery.This investigator initiated single-blinded randomized control trial will be conducted on patients who will be admitted for calcaneal surgery at Sancheti hospital, Pune, India. This trial will be started after getting the CTRI registration and Ethics committee approval from institute. Written informed consent will be obtained from the eligible patients fulfilling the inclusion criteria. After obtaining written informed consent, we will enrol 60 patients undergoing calcaneal surgery.
We will explain how to report pain using the 11-point numerical rating scale (NRS), with ‘0’ corresponding to no pain and ‘10’ being the worst possible pain. Standard fasting guidelines will be followed for all.
Outcome measures
1. The times of rescue analgesia and the adverse reactions caused by the analgesics such as pruritus, nausea and vomiting were recorded.
2. The visual assessment scale (VAS) was used to assess the pain of patients immediately after discharge from the operating room (T1), at 1st (T2), 2nd (T3), 4th (T4), 8th (T5), 12th (T6), and 24th (T7) hour after operation.
3. The satisfaction of the surgeon and of patients the satisfaction with respect to the block received on Likert scale of 1-5 ( 1: least likely and 5: most likely)
4. Total tramadol consumption in 24 hours
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults of either gender aged between age between 18- and 80-years with American Society of Anesthesiologists (ASA) physical status I to III undergoing calcaneal surgery.
排除标准
- •Patients with coagulopathy, sepsis, hepatic or renal failure
- •allergy to local anesthetic (LA) 3.Inability to consent to the study
- •Patients having opioids previously
- •Patients with pre-existing neuropathies
- •Patients with local infection around the needle site.
结局指标
主要结局
The times of rescue analgesia and the adverse reactions caused by the analgesics such as
时间窗: time to anlgesia requirement when patient demandsin first 24 hours
pruritus, nausea and vomiting will be recorded.
时间窗: time to anlgesia requirement when patient demandsin first 24 hours
次要结局
- 1.The visual assessment scale (VAS) was used to assess the pain of patients immediately after discharge from the operating room (T1), at 1st (T2), 2nd (T3), 4th (T4), 8th (T5),2th (T6), and 24th (T7) hour after operation.(2.The satisfaction of the surgeon and patients the satisfaction concerning the block received on a Likert scale of 1-5 ( 1: least likely and 5: most likely))
研究者
Dr Sandeep Diwan
Sancheti Institute for Orthopedics and Rehabiliation