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临床试验/NCT04266236
NCT04266236已完成不适用

Ultrasound-guided Lumbar Plexus Combined with Quadratus Lumborum Block Using Single-needle Technique with Shamrock Method for Hip Arthroplasty

Shanghai 6th People's Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年7月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
sensory block assessment

研究概览

简要总结

Total hip arthroplasty (THA) is one of the most successful orthopedic procedures to effectively relieve pain and restore function in patients with hip osteoarthritis, osteonecrosis of femoral head and hip fracture.The Lumbar Plexus Block (LPB) is currently used as the standard regional anesthesia technique to provide postoperative pain management after THA. The lumbar plexus (LP) originates from T12 to L5. In general, multiple-needle nerve blockade procedure is needed to block different branches of LP. Therefore, we need more time to finish the regional anethesia procedure and it's not easy for an inexperienced anesthesiologist to master the technique absolutely. In addition, multiple injections will increase the discomfort of the patients. We aim to investigate the effects of lumbar plexus combined with quadratus lumborum block using single-needle technique with Shamrock method as an alternative regional anesthesia.

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) between 18.5 and 30kg/m2 and the weight ≥50kg
  • American Society of Anesthesiologists (ASA) classification I-II
  • Postero-lateral operative incision approach unilateral hip arthroplasty

排除标准

  • Patient refusal
  • Patients with coagulopathy or on therapeutic anticoagulation
  • Multiple trauma
  • Hypersensitivity or allergy to ropivacaine
  • History of ankylosing spondylitis or spinal surgery
  • Lower extremity neuropathy
  • Unable to communicate

研究组 & 干预措施

L3 LPB technique (P group)

Active Comparator

ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique

干预措施: L3 LPB (Procedure)

L3 LPB technique (P group)

Active Comparator

ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique

干预措施: 0.375%ropivacaine 25 ml (Raropin) (Drug)

L3 LPB technique (P group)

Active Comparator

ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique

干预措施: General anesthesia with tracheal intubation (Procedure)

T12 combined with L3 and L4 LPB technique (TP group)

Active Comparator

ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique

干预措施: L3 LPB (Procedure)

T12 combined with L3 and L4 LPB technique (TP group)

Active Comparator

ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique

干预措施: L4 LPB (Procedure)

T12 combined with L3 and L4 LPB technique (TP group)

Active Comparator

ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique

干预措施: T12 block (Procedure)

T12 combined with L3 and L4 LPB technique (TP group)

Active Comparator

ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique

干预措施: 0.375%ropivacaine 40 ml (Raropin) (Drug)

T12 combined with L3 and L4 LPB technique (TP group)

Active Comparator

ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique

干预措施: General anesthesia with tracheal intubation (Procedure)

L3 LPB combined with QLB (LPQLB-SNT, PQ group)

Experimental

ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique

干预措施: L3 LPB (Procedure)

L3 LPB combined with QLB (LPQLB-SNT, PQ group)

Experimental

ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique

干预措施: L3 QLB (Procedure)

L3 LPB combined with QLB (LPQLB-SNT, PQ group)

Experimental

ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique

干预措施: 0.375%ropivacaine 40 ml (Raropin) (Drug)

L3 LPB combined with QLB (LPQLB-SNT, PQ group)

Experimental

ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique

干预措施: General anesthesia with tracheal intubation (Procedure)

结局指标

主要结局

sensory block assessment

时间窗: 30 minutes after nerve block procedure

The sensory block will be assessed by cold alcohol swab and pinprick at lateral, anterior and medial areas of thigh and postero-lateral area of gluteus using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.

次要结局

  • postoperative static pain at timepoint 2(at 6 hours after surgery)
  • postoperative static pain at timepoint 1(at 30mins after the patient recover from general anesthesia)
  • postoperative static pain at timepoint 3(at 12 hours after surgery)
  • Cumulative doses of intraoperative vasoactive medications(during the operation)
  • postoperative static pain at timepoint 4(at 24 hours after surgery)
  • Incidence of block related adverse events(within 24hours after nerve block procedure)
  • Performance time of block(During nerve block procedure)
  • intraoperative sufentanil dosage(during the operation)

研究者

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

Xiaofeng WANG

Attending doctor

Shanghai 6th People's Hospital

研究点 (1)

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