跳至主要内容
临床试验/NCT06407544
NCT06407544尚未招募不适用

Prospective Comparative Study Between Ultrasound-guided Quadratus Lumborum Block Versus Fascia Iliaca Compartment Block for Postoperative Pain and Cognitive Dysfunction Management in Patient Undergoing Hip Surgery

Sohag University0 个研究点目标入组 60 人开始时间: 2024年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
VAS score

研究概览

简要总结

Hip fractures are more common in older people due to osteoporosis. It is estimated that around six million patients worldwide will suffer hip fractures annually by 2050 as the population ages [1]. Clinically, hip surgery is a common and effective treatment for hip fractures. There will be an increasing number of older people undergoing hip surgery, including osteosynthesis and arthroplasty. However, severe surgical trauma, postoperative pain, and postoperative cognitive dysfunction (POCD) can be a considerable challenge for older people undergoing hip surgery [2, 3].The successful use of QLB with all approaches has been reported in case reports for the following surgical procedures: proctosigmoidectomy, hip surgery, above-knee amputation, abdominal hernia repair, breast reconstruction, colostomy, closure, radical nephrectomy, lower extremity vascular surgery, total hip arthroplasty, laparotomy, and colectomy.

Ultrasound-guided quadratus lumborum block (QLB) is a recently described fascial plane block in which the anesthetic is injected adjacently to the quadratus lumborum (QL) muscle with the goal of anesthetizing the nerves in the thoracolumbar region [17,18]. As a trunk nerve block, quadratus lumborum block (QLB) has been widely used for postoperative analgesia in patients undergoing abdominal and lower limb surgeries [19].

QLB can provide adequate analgesia and reduce opioid requirements after hip surgery [20]FICB or fascia iliaca block (FIB), first proposed in 1989, is a means ofblocking the three principal lumbar plexus nerves of the thigh with a single injection of local anesthetic delivered immediately dorsal to the fascia iliaca [21,22]. Indications of FICB are surgical anesthesia to the lower extremity, management of cancer pain and pain owing to inflammatory conditions of the lumbar plexus, and amelioration of acute pain following trauma, fracture, and burn [23]. Fascia Iliaca Block (FIB), which is widely used for postoperative analgesia in hip surgery, is a nerve block technique with proven efficacy[24].

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
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 65 years ASA 1 , ASA 2 Montreal Cognitive Assessment (MoCA) score ≥ 26 before surgery scheduled for hip surgery

排除标准

  • patient refusal History of chronic pain or daily use of analgesics History of psychiatric disorder or inability to understand the consent form or how to use a visual analog scale (VAS) for pain measurement inability to communicate appropriately Allergy to any required drugs alcohol abuse Local infection at the injection site contraindications to neuraxial anesthesia long-term use of antidepressants or narcotic analgesics

研究组 & 干预措施

Group (Q):

Active Comparator

including 20 patients with hip fractures will undergo ultrasound guided anterior QLB, will be administered 0.3 ml/kg of 0.125% bupivacaine (containing 1 mic/ml of dexmedetomidine and 5 mg of dexamethasone).

干预措施: peripheral nerve block (Procedure)

Group (Q):

Active Comparator

including 20 patients with hip fractures will undergo ultrasound guided anterior QLB, will be administered 0.3 ml/kg of 0.125% bupivacaine (containing 1 mic/ml of dexmedetomidine and 5 mg of dexamethasone).

干预措施: PCA device as rescue medication with IV morphine 1mg if VAS more than 4 (Drug)

Group (F):

Active Comparator

including 20 patients with hip fractures will undergo ultrasound guided FIB, will be administered 0.3 ml/kg of 0.125% bupivacaine (containing 1 mic/ml of dexmedetomidine and 5 mg of dexamethasone).

干预措施: peripheral nerve block (Procedure)

Group (F):

Active Comparator

including 20 patients with hip fractures will undergo ultrasound guided FIB, will be administered 0.3 ml/kg of 0.125% bupivacaine (containing 1 mic/ml of dexmedetomidine and 5 mg of dexamethasone).

干预措施: PCA device as rescue medication with IV morphine 1mg if VAS more than 4 (Drug)

Group (C):

Active Comparator

including 20 patients with hip fractures will receive ultrasound scanning for QLB or FIB with saline injection [26].

干预措施: peripheral nerve block (Procedure)

Group (C):

Active Comparator

including 20 patients with hip fractures will receive ultrasound scanning for QLB or FIB with saline injection [26].

干预措施: PCA device as rescue medication with IV morphine 1mg if VAS more than 4 (Drug)

结局指标

主要结局

VAS score

时间窗: 2 years

measure pain intensity (0-10)with scores ranging from 0 (no pain) to 10 (the worst possible pain).

MOCA score

时间窗: 2 years

measure post operative cognitive dysfunctionThe MOCA scores including visuospatial ability, naming, short-term memory, attention, language, abstraction, delayed recall, and orientation. MoCA states ranges may be used to grade severity: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hassan Ahmed Mohamed

assistant lecteurer anaethesia and ICU and pain management department sohag univerisity hospital

Sohag University

相似试验