The Acceptance, Safety, and Efficacy of Needle-free Jet Anaesthetic Technique (MadaJet) Versus Needle Injection for Sperm Retrieval in Patients With Azoospermia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
To compare the acceptance, safety, and efficacy of needle-free jet anaesthetic technique (MadaJet) versus needle injection for sperm retrieval in patients with azoospermia.
详细描述
Azoospermia is found in 1-3% of general population and 10-15% of men presenting with infertility. In this scenario, there are no spermatozoa in the patient's semen after centrifugation, and pregnancy may be achieved through IVF/ Intracytoplasmic sperm injection (ICSI) combined with sperm retrieval techniques (e.g. PESA, testicular sperm extraction - TESE, TESA). These techniques are commonly conducted under local anesthesia, which a 10-15 mL solution of 2% lidocaine hydrochloride injected around the spermatic cord near the external inguinal ring. However, needle fear is prevalent in both children (~33-63%) and adults (~14-38%) and can contribute to negative experiences with needle procedures and health care for patients, caregivers, and health professionals. In clinical practice, patients often concern about the pain, trauma and possible complication (i.e. wheal, hematoma, infection) of needle injection of local anaesthesia into and through the scrotal wall when performing sperm retrieval. It not only interferes with clinicians' abilities to carry out procedures (e.g. due to flailing and attempts to escape), but also undermines the efficacy of pain interventions at the time of the needle. Therefore, receiving local anaesthesia without a needle is easily well accepted by the patients with azoospermia.
The needleless jet injector (MadaJet Medical Injector) has been widely used in the fields of dermatology, cosmetic and plastic surgery, gynecology, dentistry, and podiatry as well as for immunization. It was also employed for no-scalpel vasectomy in Urology/Andrology. The first studies using needleless jet injector for spermatic cord block was reported by Wilson in 2001 and Weiss in 2005. The next studies showed that MadaJet has better outcomes (e.g. cost, pain scores, onset time) than traditional needle anaesthesia (16-18). Unlike a conventional spermatic cord block with needle injection, there is no wheal on the patients' skin and local edema after administering injection. A mist of solution with a high-pressure injector will be rapidly delivered and absorbed through the skin to the tissue beneath around the cord with much less trauma. As a consequence, it is less painful than the needle injection.
For those reasons, a needle-free jet anaesthetic technique for sperm retrieval will be described for local anaesthesia, which may minimize the fear of the needle. The acceptance, safety, and efficacy of this technique will also be compared with needle injection for sperm retrieval in azoospermia patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 100 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients (including obstructive azoospermia and non-obstructive azoospermia) in need of sperm retrieval (PESA, TESE) for ICSI.
排除标准
- •Have not finished the process of sperm retrieval techniques.
- •Malformation of genital organs (e.g. spermatic cord, testicle)
- •Anxious, alcoholic patients.
- •Patients giving a history of personality disorders.
- •Patients who abuse drugs.
- •Disagree to participate in the study.
研究组 & 干预措施
MadaJet
Jet injector (Madajet medical Urology) preloaded as manufacturer's instruction
干预措施: Madajet (Procedure)
Needle injection
01 sterile 10-mL syringe with small gauge needle (25 ga), solution for sterile preparation, 10 - 15 mL Lidocaine 2%
干预措施: Needle injection (Procedure)
结局指标
主要结局
Pain score
时间窗: 1 year
Right after completing the injection, information about the pain before, during and after the sperm retrieval technique will be immediately documented by the visual analog scale (VAS) questionnaire on 10 cm lines (0 represents no pain, whereas 10 marks the highest score).
次要结局
- Onset of action of Madajet(1 year)
- Pressure (fear) of the patients(1 year)
- Incidence of treatment (Bleeding)(1 year)
- Incidence of treatment (Swelling)(1 year)
- Onset of action of Needle injection(1 year)
- Discomfort of the patients(1 year)
- Incidence of treatment (Hematoma)(1 year)
- Duration of action of Needle injection(1 year)
- Duration of action of Madajet(1 year)
研究者
Manh Tuong Ho
Director
Vietnam National University
