Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty In Terms Of Postoperative Pain Control And Early Mobilization
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Post-operative pain assessed by Numeric Rating Scale(NRS)
研究概览
简要总结
Femoral and adductor nerve blocks with ultrasonography(USG) guidance are used effectively and efficiently in post-operative pain management in lower extremity surgical procedures. However, the superiority of these two blocks to each other is still controversial. In this prospective, randomized, double-blind study, patients who underwent elective unilateral knee arthroplasty under spinal anesthesia, will be performed postoperative femoral block or middle adductor canal block with the guidance of USG.Patients who underwent spinal anesthesia and needed sedoanalgesia and who had to switch to general anesthesia will be excluded from the study. The patients will be divided into two groups by simple randomization. Since a total of 52 patients should be included in the study as a result of the power analysis (G-power 3.1); It is planned to take approximately 26 patients for each group.The anesthesiologist, who follows the pain control and mobilization after the block, will not know which study group the patient is in. The blocks will be performed behind the cover while the patient is under spinal anesthesia (Thus, the point of application of the block will not be noticed). In this way, the patient and the anesthesiologist who follows the parameters after the block will be blind to patient's arm. In the first group, 0.25% 20 ml of local anesthetic and middle adductor canal block, in the second group 0.25% 20 ml of local anesthetic and femoral nerve block will be applied We will compare these two blocks in terms of early mobilization, postoperative pain control, motor, and sensory block.
详细描述
All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and "Numeric Rating Scale" for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll. Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group.Femoral block or middle adductor canal block will be applied to the patients.
Group1 (Group 1 Middle Adductor Canal Block) patients will be administered middle adductor canal block with 20 ml 0.25% Bupivacaine by an experienced anesthesiologist.
Group2 (Femoral Nerve Block) patients will be administered femoral block with 20 ml 0.25% Bupivacaine by an experienced anesthesiologist.
The selected block will be applied with USG behind the curtain after the operation.Patients will be taken to the postoperative recovery unit.Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Post-operatively, patients will receive 1mg/kg Tramadol when Numeric Rating Scale(NRS) > 3.The duration of the sensory and motor block and the mobilization of the patients will be recorded and compared.
0,2,4,6,8,12,24 of the patient pain scores at hour and 6 months, presence of sensory block and motor block, pain score when the patient is mobilized will be recorded.In addition, operation time, complications related to block, mobilization time, discharge day, and opioid need will be recorded.It will be recorded at what time the first opioid dose was administered after the block.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA1-2-3 patients who will undergo unilateral elective primary total knee prosthesis surgery with consent for the study
- •Patients whose operation has been successfully completed with spinal anesthesia
排除标准
- •Refusal of the patient to work
- •Patients under 18 years of age
- •Patients who have undergone an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, sedoanelgesia, laryngeal mask application, etc.)
- •Those with known local anesthetic allergies
- •Body mass index> 35 patient groups
- •Skin infection at the injection site
- •Coagulopathy and use of anticoagulant therapy
- •Uncontrolled diabetic patients
- •Uncooperative patient
- •Physiological and emotional lability
- •Prolonged surgical intervention
- •Patient with limitation of mobilization and movement before the operation, other than the operation reason
研究组 & 干预措施
Group 2 Femoral Nerve Block.
Ultrasound Guided Femoral Nerve Block:
20 ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block.
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
干预措施: Bupivacain (Drug)
Group 1 Middle Adductor Canal Block
Ultrasound Guided Middle Adductor Canal Block:
20 ml Bupivacaine 0.25% Injectable Solution will be administered for middle adductor canal block.
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
干预措施: Ultrasound Guided Middle Adductor Canal Block (Procedure)
Group 1 Middle Adductor Canal Block
Ultrasound Guided Middle Adductor Canal Block:
20 ml Bupivacaine 0.25% Injectable Solution will be administered for middle adductor canal block.
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
干预措施: Bupivacain (Drug)
Group 1 Middle Adductor Canal Block
Ultrasound Guided Middle Adductor Canal Block:
20 ml Bupivacaine 0.25% Injectable Solution will be administered for middle adductor canal block.
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
干预措施: Spinal Anesthesia (Procedure)
Group 2 Femoral Nerve Block.
Ultrasound Guided Femoral Nerve Block:
20 ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block.
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
干预措施: Ultrasound Guided Femoral Nerve Block. (Procedure)
Group 2 Femoral Nerve Block.
Ultrasound Guided Femoral Nerve Block:
20 ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block.
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
干预措施: Spinal Anesthesia (Procedure)
结局指标
主要结局
Post-operative pain assessed by Numeric Rating Scale(NRS)
时间窗: At 6 months postoperatively
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
NRS at Ambulation
时间窗: 48 hours postoperatively
NRS when first time a patients can walk around independently
Ambulation time
时间窗: 48 hours postoperatively
First time a patients can walk around independently
次要结局
- Time of Return of Motor Block(24 hours postoperatively)
- Time of First Rescue Opioid(48 hours postoperatively)
- Time of Return of Sensory Block(24 hours postoperatively)
研究者
Elif Göktaş
Anesthesiology Resident
Bozyaka Training and Research Hospital