The Effect of Adding Dexamethasone Versus Magnesium Sulphate Versus Dexmedetomidine to Bupivacaine in Ultrasound Guided Adductor Canal Block for Post-operative Analgesia Following Anterior Cruciate Ligament Repair
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- rescue analgesia time
研究概览
简要总结
Adult patients undergoing anterior cruciate ligament repair under Spinal Anaesthesia will be randomly assigned into one of the following groups (The Four study groups will receive the standard treatment in the form of spinal anesthesia and adductor canal block), using computer generated codes and opaque sealed envelopes:
- Group DX(DEXAMETHASONE): The patients receive 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) in adductor canal block after spinal anaetthesia.
- Group DM (dexmedetomidine)The patients receive 20 ml plain bupivacaine(0.5)+25 microgram dexmedetomidine( diluted in 2 ml normal saline) in adductor canal block after spinal anaetthesia.
- Group M (magnesium sulphate):The patients receive 20 ml plain bupivacaine(0.5)+200 milligram magnesium sulphate (2 ml of magnesium 10%) in adductor canal block after spinal anaetthesia.
- Group C(CONTROL): The patients receive 20ml plain bupivacaine (0.5%) + 2 ml of Normal saline in adductor canal block after spinal anaetthesia.
详细描述
All patients will clinically be assessed and routine preoperative investigations will be done; CBC, Coagulation profile, liver function tests, kidney function tests, fasting blood sugar and ECG.
B. Intraoperative settings:
On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied.
Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be also recorded, All patients in this study will be positioned similarly during the entire surgical procedure and the whole procedures will be done by the same team.
Intravenous (IV) line will be inserted, and IV lactated Ringer will be started.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
using computer generated codes and opaque sealed envelopes:
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years.
- •Sex: Both sexes.
- •Height 155-170 cm.
- •American Society of Anaesthesiologists (ASA) Physical Status Class-I and II.
- •Scheduled for anterior cruciate ligament under spinal anaesthesia.
排除标准
- •Declining to give written informed consent.
- •History of allergy to the medications used in the study.
- •Contraindications to regional anesthesia (including coagulopathy and local infection).
- •Psychiatric disorder.
研究组 & 干预措施
Group DX
The patients receive 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) in adductor canal block after spinal anesthesia
干预措施: Dexamethasone (Drug)
Group DM
The patients receive 20 ml plain bupivacaine(0.5%)+25 microgram dexmedetomidine( diluted in 2 ml normal saline) in adductor canal block after spinal anesthesia .
干预措施: Dexmedetomidine (Drug)
Group M
The patients receive 20 ml plain bupivacaine(0.5%)+200 milligram magnesium sulphate (2 ml of magnesium 10%) in adductor canal block after spinal anesthesia.
干预措施: Magnesium sulfate (Drug)
Group C
The patients receive 20ml plain bupivacaine (0.5%) + 2 ml of Normal saline in adductor canal block after spinal anesthesia.
干预措施: Bupivacain (Drug)
结局指标
主要结局
rescue analgesia time
时间窗: first 24 hours postoperatively
time to first analgesic requirement
次要结局
- rescue analgesia(24 hours)
研究者
Ismail Mohammed
lecturer of anesthesia
Ain Shams University