Effect of Superficial Cervical Plexus Block on Incidence and Severity of Post Operative Nausea and Vomiting in Tympanomastoid Operations in Adults, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- PONV incidence over 24hour postoperative
研究概览
简要总结
post operative nausea and vomiting are very common after tympanomastoid operations, in this study we are investigating the effect of superficial cervical plexus block on the incidence and severity of those post operative complications.
详细描述
various treatments and regimens have been tried to overcome the problem of postoperative nausea and vomiting after tympanomastoid surgery. superficial cervical plexus block seems so promising in this regards as it may reduce the incidence and severity of PONV through 3 mechanisms: primarily through blocking vagal afferents to the middle ear which mediate the vomiting reflex, and secondarily through decreasing pain which aggravates PONV, and finally through decreasing intra and post operative opioid consumption due to adequate analgesia which in turn avoids opioids side effects including PONV.
the study group will receive superficial cervical plexus block while the control will receive the same block while given placebo instead of (lidocain/bupivacaine mixture) incidence and severity of PONV will be recoded according to a scale to find the difference between both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients belonging to American Society of Anesthesiologists physical status I-II.
- •operation time less than 4 hours.
排除标准
- •• American Society of Anesthesiology (ASA) physical status ≥ III.
- •Uncooperative or mentally retarded patients.
- •Known Allergy or hypersensitivity to lidocaine or bupivacaine.
- •Patients known to have gastritis or Gastro-oesophageal reflux disease (GERD).
- •History of PONV or motion sickness.
- •Operation duration (short less than 30 minutes or prolonged more than 240 min).
- •Patients with chronic renal disease (serum creatinine level ≥2.0mg/dl) or on renal replacement therapy (dialysis).
- •Patients with chronic cholecystitis (history of recurrent or persistent vomiting)
- •Skin inflammation and cellulitis.
研究组 & 干预措施
group B
Superficial cervical plexus block (SCP) block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize superficial cervical plexus (SCP) posterior to the midpoint of sterno cleido mastoid (SCM) muscle. Once SCP is identified, a combination of 5 ml bupivacaine (0.5%) and 5 ml lidocaine (2%) is injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel Echogenic Needle.
干预措施: ultrasound guided superficial cervical plexus block (Procedure)
group S
SCP block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize SCP posterior to the midpoint of SCM muscle. Once SCP is identified, 10 ml of normal saline is injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel Echogenic Needle.
干预措施: ultrasound guided superficial cervical plexus block (Procedure)
结局指标
主要结局
PONV incidence over 24hour postoperative
时间窗: 24 hours
incidence of PONV according to PONV score from 0 to 3 where: 0= No nausea,no vomiting, 1= Nausea present, no vomiting, 2= Nausea present, vomiting present, 3= Vomiting\>2 episodes in 30 minutes, i.e., number of patients with PONV score of 0, number of patients with PONV score of 1, number of patients with PONV score of 2 and number of patients with PONV score of 3.
次要结局
- Need for postoperative analgesia(24 hours)
- To detect complications of regional ear block(24 hours)
- post operative pain score measured by visual analogue score (VAS) from 0 to 10, where 0= no pain and 10= unbearable pain.(up to 24 hours postoperative)
- Intraoperative and postoperative complications(24 hours)
- To monitor intraoperative hemodynamics(up to 4 hours)
- Side effects and toxicity of drugs(24 hours)
研究者
Wael El-Siory
Lecturer of anesthesia and intensive care medicine- Faculty of Medicine
Cairo University