Improving Patient Outcomes With Inguinal Hernioplasty - a Randomized Controlled Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale
研究概览
简要总结
The aim of this RCT is to compare patient outcomes of inguinal hernioplasty under Local Anaesthesia alone versus Local Anaesthesia and Conscious Sedation
Specific study objectives are to determine the effect of conscious sedation on:
(i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative complications (v) postoperative functional status (vi) short-term postoperative complications (vii) long-term postoperative complications
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
- Triple (Participant, Investigator, 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
- 否
入选标准
- •Reducible inguinal hernia
排除标准
- •Renal, hepatic, respiratory, cardiovascular, neurologic or psychiatric disease
- •Body mass index < 18.5 kg/m2 or > 30 kg/m2
- •Recurrent inguinal hernias
- •Bilateral inguinal hernias
- •Large inguinoscrotal hernias
- •Incarcerated hernia
- •Allergies to local anaesthetic and sedative agents
- •Pregnancy
- •Lactation
- •Chronic pain syndromes
- •Anxiety disorders
- •Marijuana use
- •Long term use of opioid or sedative agents
研究组 & 干预措施
Intravenous Normal Saline
Intravenous Normal Saline plus Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg ; Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus i
干预措施: Intravenous Normal Saline (Drug)
Intravenous Normal Saline
Intravenous Normal Saline plus Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg ; Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus i
干预措施: Bupivocaine (Drug)
Intravenous Normal Saline
Intravenous Normal Saline plus Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg ; Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus i
干预措施: Lignocaine HCl (Drug)
Midazolam
Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus Midazolam - administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg.
干预措施: Midazolam (Drug)
Midazolam
Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus Midazolam - administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg.
干预措施: Bupivocaine (Drug)
Midazolam
Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus Midazolam - administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg.
干预措施: Lignocaine HCl (Drug)
结局指标
主要结局
patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale
时间窗: 1 year
Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)
次要结局
- Post-operative assessment of physical activity using Activities Assessment Scale(1 year)
- Time to discharge(2 weeks)
- change in postoperative pain score from baseline assessed with visual analog scale(1 year)
- Frequency (total count) of postoperative complications using a questionaire(1 year)
- Operative time(2 weeks)