Does Perineural Dexamethasone Increase the Duration of an Ulnar Nerve Block When Controlling for Systemic Effects? A Randomised, Blinded, Placebo-controlled, Paired, Non-inferiority Trial in Healthy Volunteers.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Duration of the sensory nerve block, assessed by temperature discrimination (cold swab)
研究概览
简要总结
Investigators will assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for systemic effects in healthy volunteers.
详细描述
Healthy volunteers will have bilateral ulnar nerve blocks performed with bupivacaine on two different days with a minimum of 14 days wash-out. On one day, the participants will also receive dexamethasone in one arm and placebo in the other. On the other day, the participants will also receive placebo in one arm and lidocaine in the other. By this using this design, the investigators will be able to assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for the systemic effects. Furthermore, to ensure blinding, the investigators have also incorporated the lidocaine group which also allows for the assessment of the effects of adding lidocaine to a peripheral nerve block with bupivacaine. The order of which the participant will receive dexamethasone and lidocaine will be random. It will also be random in which arm the participant receives dexamethasone and lidocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The trial medication will be identical in appearance and will be prepared in syringes of identical appearance with an identical volume of trial medication by an un-masked nurse who is not otherwise involved in the trial. The participant, anaesthesiologist performing the blocks, the investigators, and the outcome assessors for all outcomes will be masked to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 18 years or above
- •Must fully understand the protocol and sign written informed consent
- •American Society of Anaesthesiologists Physical Status Classification System of 1 or 2
- •Body Mass Index above 18 kg/m^2
- •For fertile women, safe contraceptives for the last month and negative urine human chorionic gonadotropin is required
排除标准
- •Participants unable to cooperate
- •Participants unable to speak or read Danish
- •Age above 65 years
- •Cardiovascular disease
- •Allergy to study medication
- •History of alcohol or substance abuse
- •Intake of corticosteroids within the last 14 days
- •Daily intake of prescription analgesia within the last four weeks
- •Intake of over-the-counter analgesia within the last 48 hours
- •Neuromuscular diseases or wounds on the arms or hands preventing adequate test or block performance.
- •Diabetes mellitus
研究组 & 干预措施
Perineural dexamethasone
Bilateral ulnar nerve blocks with bupivacaine. Dexamethasone will be added perineurally in this arm on the same day as the 'systemic dexamethasone' group.
干预措施: Perineural dexamethasone (Drug)
Systemic dexamethasone
Bilateral ulnar nerve blocks with bupivacaine. Placebo (saline) will be added perineurally in this arm on the same day as the 'perineural dexamethasone' group. Thereby, this ulnar nerve block will only be affected by the perineurally added dexamethasone that is absorbed and redistributed systemically.
干预措施: Systemic dexamethasone (Drug)
Placebo
Bilateral ulnar nerve blocks with bupivacaine. Placebo (saline) will be added perineurally in this arm on the same day as lidocaine group. This will be the actual placebo group.
干预措施: Placebo (Drug)
Perineural lidocaine
Bilateral ulnar nerve blocks with bupivacaine. Lidocaine will be added perineurally in this arm on the same day as the actual placebo group.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Duration of the sensory nerve block, assessed by temperature discrimination (cold swab)
时间窗: 24 hours
The investigators will stimulate the skin with an alcohol swab and ask the participant if it is cold or warm. The duration of the sensory block will be defined as the time to the alcohol swab feels cold again. The investigators will assess temperature discrimination every 30 minutes.
次要结局
- Duration of the sensory nerve block, assessed by mechanical discrimination (pinprick)(24 hours)
- Duration of analgesia, assessed by pain during tonic heat stimulation (heated thermode)(24 hours)
- Duration of the motor block, assessed by fifth finger abduction(24 hours)
- Onset of the sensory nerve block, assessed by temperature discrimination (cold swab)(24 hours)