Impact of Intravenous Dexamethasone on the Duration of Motor and Sensory Block Following Spinal Anesthesia With Chloroprocaine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Regression of sensory block by 2 dermatomes
研究概览
简要总结
The purpose of this study is to compare the effect of a single dose of 8 mg of intravenous dexamethasone versus placebo on the duration of sensory and motor block after spinal anesthesia with chloroprocaine.
详细描述
Spinal anesthesia is commonly used for lower body surgery. The injection of local anesthetics in the lumbar intrathecal space allows the desensitization of the lower body by blocking sensory and motor nerve roots. In return, spinal anesthesia causes a sympathetic block which is associated with deleterious hemodynamic effects such as hypotension.
Isobaric chloroprocaine is a local anesthetic increasingly used for spinal anesthesia to reduce the duration of sensory and motor blocks compared to bupivacaine, allowing for faster postoperative recovery. However, certain medications used during surgery may possibly influence the duration of spinal anesthesia. Among these is dexamethasone, a drug belonging to the corticosteroid family. Dexamethasone is a well-known and commonly used medication in anesthesia to prevent postoperative nausea and vomiting. It is also used by anesthesiologists to reduce pain in the context of fast functional recovery after surgery. The safety of single-dose intravenous dexamethasone is therefore established in the context of anesthesia for several types of surgery.
Medical literature demonstrates that dexamethasone can prolong the effect of certain local anesthetics when administered intravenously or perineurally (near the nerves), and sometimes has no effect on the duration of local anesthetics administered for spinal anesthesia. Currently, no information is available in the literature on the effect of intravenous dexamethasone on the duration of a spinal anesthesia with isobaric chloroprocaine.
This study aims to compare the effect of a single dose of 8 mg of intravenous dexamethasone versus placebo on the duration of sensory and motor block after spinal anesthesia with chloroprocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients in both groups will receive the study drug (dexamethasone or placebo) in the same volume of normal saline. The study drug will be prepared by an independent assistant.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 90 years old
- •ASA status I to III inclusively
- •Planned lower body surgery under spinal anesthesia with chloroprocaine
- •Signed informed consent form
排除标准
- •Contraindication to spinal anesthesia: infection at the puncture site, congenital or acquired coagulopathy
- •Preexisting neuropathy or nerve block that could interfere with study assessments
- •Allergy or hypersensitivity to local anesthetics, dexamethasone, or other medications used in the study
- •Preoperative use of corticosteroids
- •Patient refusal
- •Inability to consent
- •Language barrier, psychiatric, physical, or mental condition making sensory and motor blocks assessment impossible despite prior instruction
- •Administration of any intrathecal adjuvant (fentanyl, morphine, clonidine, dexmedetomidine, epinephrine, or others) along with chloroprocaine
- •Perioperative intravenous dexmedetomidine administration
- •Conversion to general anesthesia
- •Impossible post-anesthesia care unit assessment: patient still intubated / transfer to intensive care unit, research team constraints, or other reasons
- •Assessment in the recovery room impossible: medical condition (shock, delirium, major agitation, altered state of consciousness, or other), transfer to the intensive care unit, research team constraints, or other
研究组 & 干预措施
Intravenous normal saline
During the performance of spinal anesthesia using isobaric 1% chloroprocaine 50 mg, an intravenous infusion of 2 ml of Normal Saline will be initiated. The normal saline will be administered intravenously over one minute. The study drug will be prepared by an independent assistant.
干预措施: Normal Saline (Drug)
Intravenous dexamethasone
During the performance of spinal anesthesia using isobaric 1% chloroprocaine 50 mg, an intravenous infusion of dexamethasone 8 mg (2 ml) will be initiated. The study drug will be administered intravenously over one minute. The study drug will be prepared by an independent assistant.
干预措施: Intravenous Dexamethasone (Drug)
结局指标
主要结局
Regression of sensory block by 2 dermatomes
时间窗: At regression of spinal anesthesia by 2 dermatomes, approximately 60 minutes after surgery
Loss of pinprick sensation by Von Frey filaments from the injection of chloroprocaine for spinal anesthesia until regression of the sensory block by two dermatomes from the peak sensory level
次要结局
- Quality of motor block(Up to 30 minutes following spinal anesthesia)
- Duration of motor block(At 5,10,15 and 20 minutes following spinal anesthesia, then every 10 minutes until complete recovery, approximately 90 minutes after surgery)
- Time until the first observable regression of the motor block(At 5,10,15 and 20 minutes following spinal anesthesia, then every 10 minutes until complete recovery, approximately 90 minutes after surgery)
- Onset of sensory block(Up to 30 minutes following spinal anesthesia)
- Onset of motor block(Up to 30 minutes following spinal anesthesia)
- Opioid consumption(At recovery room discharge, approximately one hour after the end of surgery)
- Antiemetic consumption(At recovery room discharge, approximately one hour after the end of surgery)
- Incidence of hypotension(From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery)
- Incidence of bradycardia(From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery)
- Incidence of nausea(From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery)
- Incidence of vomiting(From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery)
- Incidence of itching(From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery)
- Incidence of urinary retention(From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery)
- Incidence of shivering(From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery)
- Incidence of headache(From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery)
- Quality of postoperative recovery(At 24 hours after the surgery)
- Intensity of nausea/vomiting(At 24 hours after surgery)
- Pain intensity(At 24 hours after surgery)
- Quality of sleep(At 24 hours after surgery)
- Surgeon's satisfaction towards spinal anesthesia(At the end of surgery, on the day of randomization)