Comparison of Adductor Canal Block, Peri-articular Injection or Infiltration Between Popliteal Artery and Posterior Knee Capsule (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-operative pain
研究概览
简要总结
This is a prospective randomized double blind controlled study to evaluate the post-operative analgesic effect of adductor canal block (ACB) or peri-articular injection (PAIs) compared to combined adductor canal block and infiltration of the interspace between popliteal artery and the capsule of posterior knee block ( IPACK) in patient undergoing total knee arthroplasty
详细描述
This prospective randomized study will be carried out in Tanta University Hospitals in Anesthesia Department for one year after approval from ethical committee of faculty of medicine of Tanta university. After approval from institutional ethics committee, an informed consent will be taken from each patient. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only. Any unexpected risks encountered during the course of the research will be cleared to the participants as well as to the Ethical Committee on time. Every patient will receive an explanation to the purpose of the study and every patient will have a secret code number to ensure privacy to participants and confidentiality of data.
Inclusion criteria:
Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty will be enrolled in the study.
Exclusion criteria:
- Patient who refuse the regional anesthesia technique.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- Patients with bleeding and coagulation disorders.
- Patient with Advanced renal, hepatic and cardiac diseases.
- Preexisting lower extremity neurological abnormality, or neuropathy and difficulties in comprehending (NRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
- The patients will be blind through the use of closed sealed envelops.
- The measurement will be collected by anesthesia nurse not participating in the study and blinded to its group.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty
排除标准
- •Patient who refuse the regional anesthesia technique.
- •History of allergy to local anesthetics.
- •Local infection at the site of the block.
- •Patients with bleeding and coagulation disorders.
- •Patient with Advanced renal, hepatic and cardiac diseases.
- •Preexisting lower extremity neurological abnormality, or neuropathy and difficulties in comprehending (NRS)
研究组 & 干预措施
Adductor canal block (ACB) group
Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal
干预措施: Adductor canal block (ACB) group (Procedure)
Peri-articular injection group
Patients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon.
A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL
干预措施: Peri-articular injection group (Procedure)
Adductor canal block and IPACK block group
Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected
干预措施: Adductor canal block and IPACK block group (Procedure)
结局指标
主要结局
Post-operative pain
时间窗: After the resolution of the effect of spinal anesthesia for 72 hours postoperative
Post-operative pain will be assessed at rest and during physiotherapy by Numeric Rating Scale from (0-10) '0' representing "no pain" to '10' representing "worst pain imaginable"
次要结局
- Effect on Motor function(Each day till the third postoperative day)
- Postoperative analgesia(First 24 hours postoperatively)
- Duration of the block(First 24 hours postoperatively)
研究者
Mohamed Shebl Abdelghany
Principal Investigator
Tanta University