Competency of Coupling of IPACK Block With Adductor Canal Block Versus Adductor Canal Block Alone on Postoperative Pain, Functional Recovery and Inflammatory Response After Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement.
研究概览
简要总结
The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement as well as Functional Recovery and Inflammatory Response and range of motion postoperatively.
详细描述
Postoperative Analgesia Management and Evaluation of Outcomes:
After the total knee arthroplasty ended, the patients will be transmitted to the post anaesthesia care unit (PACU). The same multimodal postoperative analgesia will be applied in the PACU in three groups, which will be consistent with ketorolac 50 mg every twelve hours and acetaminophen 1 g i.v. every eight hours will be both applied for 3 days. If the NRS score is higher than 4, 5 mg morphine will be administered as rescue analgesia. Eight mg of odanesteron will be given when severe nausea or vomiting occurs. Enoxaparin for four weeks postoperatively will be given as a thromboembolism prophylaxis. Finally, patients will be ambulated with the help of the walker after the first ten postoperative hours.
Assessment of outcomes:
Primary outcome:
Assessment of pain after completing the surgical procedure and wear off of spinal analgesia that will be confirmed by Bromage scale and cold sensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing total knee replacement.
- •ASA physical status I to III
- •Sex (males and females).
- •Age 20 - 70 years.
排除标准
- •Patients undergoing bilateral or revision total knee replacement.
- •ASA physical status more than III
- •Age less than 20 or older than 70
- •severe renal insufficiency ( Estimated Glomerular filtration rate eGFR < 15 mL/min/1.73 m2 ).
- •history of arrhythmia or seizures.
- •Hypersensitivity to local anesthetics.
- •Preexisting peripheral neuropathy and prior vascular surgery on femoral vessels on operated site.
- •Infection near site of injection e.g. osteomyelitis, septic knee joint, etc.
- •Patient refusal or with difficulties in comprehending numeric pain rating scale (NRS) pain scores
- •Any contraindications for spinal anesthesia. (eg.: refusal of patients, coagulopathy, use of anticoagulants or antiplatelets...)
研究组 & 干预措施
Adductor canal block (ACB) + IPACK block
Group A: 25 patients will receive adductor canal block under ultrasound using 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound using 15 ml bupivacaine 0.25% at the start of surgery.
IPACK Block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of bupivacaine 0.25% will be injected after negative aspiration.
干预措施: Adductor Canal Block (ACB) + iPACK Block (Procedure)
Adductor Canal Block (ACB) + IPACK (sham injection)
Group B : 25 patients will receive Adductor canal block only under ultrasound guide using 20ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound using 15 ml of saline (sham injection) at the start of the surgery. The patients in Group B will receive ACB and IPACK block (sham injection) as described above.
干预措施: Adductor Canal Block (ACB) + iPACK Block (sham injection) (Procedure)
结局指标
主要结局
The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement.
时间窗: At 0 hour -6 hours, 6 hours-12 hours and 12 hours - 24 hours after surgery
Total cumulative dose of used morphine (mg) to control pain will be recorded at 0 hour -6 hours, 6 hours -12 hours and 12 hours - 24 hours after surgery from postoperative in post anaesthesia care unit and in orthopaedic wards as primary outcome of the study.
The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement.
时间窗: At 0 hour -6 hours, 6 hours-12 hours and 12 hours - 24 hours after surgery
Total cumulative dose of used morphine (mg) to control pain will be recorded at 0 hour -6 hours, 6 hours -12 hours and 12 hours - 24 hours after surgery from postoperative in post anaesthesia care unit and in orthopaedic wards as primary outcome of the study.
次要结局
- The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively(Range of motion and quadriceps strength will be measured after first 10 hours, three times a day with 6 hours apart.)
- The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively.(Neutrophil-lymphocytic ratio and Platelet-lymphocytic ratio will be collected at 12 hours and 24 hours postoperative.)
- The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively(Range of motion and quadriceps strength will be measured after first 10 hours, three times a day with 6 hours apart.)
- The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively.(Neutrophil-lymphocytic ratio and Platelet-lymphocytic ratio will be collected at 12 hours and 24 hours postoperative.)
- The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively(Postoperative Pain scores at rest and during active flexion 45◦ will be recorded at 8 hours, 12 hours and 24 hours postoperative.)