Comparison of Functional Outcomes and Postoperative Analgesic Efficacy Between Adductor Canal Block + IPACK Block and Adductor Canal Block + Genicular Nerve Block in Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- 6-Clicks score
研究概览
简要总结
The aim of this study is to compare the postoperative analgesic efficacy and functional outcomes of the IPACK+Adductor Canal Block with the Genicular Nerve Block+Adductor Canal Block block in patients undergoing total knee arthroplasty (TKA). The primary objective (measurable) is to evaluate functional improvement using 6-Clicks scores, while secondary objectives include pain scores (Vas Score), opioid consumption, hospital stay duration, and patient satisfaction (Patient Satisfaction Index).
IPACK : The infiltration between the popliteal artery and capsule of the knee
详细描述
Group I: Patients who underwent IPACK + Adductor canal block after TDA surgery Group G: Patients who underwent Genicular nerve block + Adductor canal block after TDA surgery
This study will be designed as a prospective randomized trial, and randomization will be performed using the sealed envelope method. This method will be carried out as follows:
First, the study will include two groups: Group I (patients who received a block between the posterior knee capsule and the popliteal artery (IPACK) + adductor canal block (AKB)) and Group G (patients who received a genicular nerve block + adductor canal block). The number of subjects in each group will be adjusted to be equal.
Simple randomization: A list will be created to assign subjects to groups using software (e.g., the RANDBETWEEN function in Excel or an online randomization tool) or a random number table. Each participant will be assigned a serial number in the randomization list (e.g., from 1 to 100). Group Assignment: A group assignment is determined for each number in the randomization list. A random sequence number will be written on each envelope. A piece of paper containing the group assignment corresponding to the number will be placed inside the envelope (e.g., "Group I" or "Group G").
The envelopes will be securely sealed and sealed to prevent any crossover between groups. The prepared envelopes will be randomly mixed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
single blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for spinal anesthesia with TDA.
- •American Society of Anesthesiologists (ASA) physical status score I-III.
- •Patients capable of providing informed consent.
排除标准
- •Active infection at the injection site.
- •Coagulopathy or systemic sepsis.
- •Severe hypovolemia.
- •Patients who refuse regional anesthesia.
- •Known allergy to local anesthetics.
- •Cognitive impairment or uncooperative patients.
研究组 & 干预措施
GROUP IPACK
ADDUCTOR CANAL BLOCK + IPACK
干预措施: Adductor Canal Block (ACB) + iPACK Block (Drug)
GROUP GENİCULAR
ADDUCTOR CANAL BLOCK + GENİCULAR BLOCK
干预措施: adductor canal block + genicular blocks (Drug)
结局指标
主要结局
6-Clicks score
时间窗: 6.,12.,24.,36.,48.,60.,72. hours
Known as "6-Clicks" due to being composed of six scored patient activity questions, a patient's "6-Clicks" score falls on a 6- to 24-point scale where a score of 6 represents total functional impairment and a score of 24 represents total absence of impairment.
次要结局
- visual analog scale(Postoperative recovery room 30 minutes and at 6., 12., 24., 36., 48., 60., and 72. hours)
- total opioid consumption(total opioid consumption 24.hour)
- The Patient Satisfaction Index(first 24. hour)
研究者
Sami Uyar
Dr.
Konya Beyhekim Training and Research Hospital