Combination of Dexamethasone and Bupivacaine Versus Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Intraoperative and Postoperative Analgesia in Patients Undergoing Lower Limb Vascular Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 主要终点
- Time of onset of motor blockade
研究概览
简要总结
In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8 hours. Increasing the duration of local anaesthetic action is often desirable because it prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing vascular absorption of the local anaesthetic. Additives like opioids, clonidine and verapamil were added to local anaesthetics, but the results are either inconclusive or associated with side effects. Steroids when used intrathecally are reported to cause arachnoiditis, but there is no evidence suggesting any neuritis when steroids are used in low concentration in peripheral nerve blocks.
Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural injection of steroids is reported to influence postoperative analgesia. They relieve pain by reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5% levobupivacaine in interscalene brachial plexus block showed improvement of postoperative analgesia for arthroscopic shoulder operation without any specific complications.
The objective of this study is to compare the effects of combining of dexamethasone and bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients undergoing lower limb vascular surgeries. The effects will be studied in terms of:
- Onset of sensory blockade and motor blockade
- Duration of analgesia / first request for analgesic
- Duration of motor blockade
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranging from 18 to 70 years
- •American Society of Anesthesiologists (ASA) physical status I, II and III
- •Patients scheduled for lower limb vascular surgeries
排除标准
- •Patient refusal for the procedure
- •Any bleeding disorder or patients on anticoagulant therapy
- •Neurological deficits involving lumbar or sacral plexuses
- •Patients with allergy to local anaesthetics
- •Local infection at the injection site
- •Patients on any sedative or antipsychotic drugs
- •Body mass index > 35
研究组 & 干预措施
perineural dexamethasone group
21 patients received perineural dexamethasone plus bupivacaine 0.5%
干预措施: Perineural Dexamethasone and bupivacaine (Drug)
systemic dexamethasone group
21 patients received systemic (intravenous) dexamethasone plus perineural bupivacaine 0.5%
干预措施: Systemic Dexamethasone plus perineural bupivacaine (Drug)
control group
21 patients received only perineural bupivacaine 0.5% plus intravenous saline
干预措施: intravenous saline plus perineural bupivacaine (Drug)
结局指标
主要结局
Time of onset of motor blockade
时间窗: up to 30 min
from time of performing the nerve block till the occurrence of motor block
Duration of analgesia
时间窗: upto 24 hours
time from onset of analgesia till the first request for an analgesic
Duration of motor blockade
时间窗: upto 24 hours
time from motor blockade till ability to move the limb
Time of onset of sensory blockade
时间窗: upto 30 min
from time of performing the nerve block till the occurrence of sensory block
次要结局
- perioperative hemodynamics(time immediately before block and every 30 minutes till end of surgery and 24 hours after surgery (1 hour interval))
研究者
Sherif Mohamed Abd el moneim Soaida, MD
Lecturer
Cairo University