Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 主要终点
- - Duration of saddle block
研究概览
简要总结
Evaluation of the anesthetic quality and analgesic efficacy of adding ketamine to intrathecal bupivavaine in selective saddle block for perianal surgery.
详细描述
This study will be carried out in Assiut University Hospitals, General Surgery Operative room and Post Anaesthesia Care Unit (PACU).
This study will include 60 adult participants (ASA I&II) scheduled for minor perianal surgery (perianal fistula, haemorrhoids or both). After approval of ethics committee and written informed consent will be obtained from the participants.
Investigators will exclude participants with classic contraindications to spinal block, pre-existing systemic disease (such as cardiovascular, respiratory or renal diseases), coagulopathy and participants taking any medications that could influence the haemodynamic response.
The selected participants will be divide into two groups (30 participants for each group), ketamine group and placebo (control) group.
The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total volume is 2 ml will injected. The control group will receive only intrathecal bupivacaine (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be included in the study only if they meet all of the following criteria:
- •Patients scheduled for perianal surgeries.
- •Age 18-55 years.
- •ASA physical status I-II.
排除标准
- •Subjects will be excluded from the study for any of the following reasons:
- •Patient refusal
- •Any contraindication of regional anaesthesia
- •Failed Technique
研究组 & 干预措施
The ketamine group
The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total volume is 2 ml will injected
干预措施: Ketamine (Drug)
The ketamine group
The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total volume is 2 ml will injected
干预措施: bupivacaine (Drug)
The control group
group will receive only intrathecal bupivacaine (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml.
干预措施: bupivacaine (Drug)
结局指标
主要结局
- Duration of saddle block
时间窗: 24 hours post-operative
(time from intrathecal injection to the time of first complain of pain, first request for analgesia, or a reported NRS \>4)
次要结局
- Evaluation of the need of supplemental analgesia(24 hours post-operative)
研究者
Esam Eldin Mohamed Abdalla
Clinical Professor
Assiut University