Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand. A Randomised, Blinded, Placebo-controlled, Parallel, Triple-arm Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Time to first pain (measured in minutes)
研究概览
简要总结
The investigators will assess the beneficial and harmful effects of oral dexamethasone (12 mg or 24 mg) versus placebo in patients undergoing orthopaedic surgery of their hand or forearm with a lateral infraclavicular brachial plexus block as the means of providing anaesthesia and analgesia.
详细描述
This is a randomised, blinded, placebo-controlled, multicentre, parallel, 3-arm clinical trial assessing the effects of adjunct oral dexamethasone (12mg or 24mg) versus placebo on time to first pain (i.e. block duration) in patients undergoing surgery of the forearm or hand. At the initiation of the trial, no other trials had examined the effects of oral dexamethasone as an adjunct to peripheral nerve blocks.
The investigators will randomise participants to either oral dexamethasone 12mg, oral dexamethasone 24mg, or placebo. Participants will be allocated according to a computer-generated random allocation sequence with random permuted blocks and stratification by site. Glostrup Pharmacy produced the trial medication and sequentially numbered the drug containers, thereby concealing the allocation.
All involved will be blinded for the entire duration of the trial (participant, carers, investigators, people delivering the intervention, observers/outcome assessors, statisticians). Blinding will not be broken until agreement has been reached within the steering committee regarding the statistical analysis. The trial medication is produced as identically appearing opaque capsules containing either dexamethasone or placebo. The trial medication is contained within identically appearing, sequentially labelled containers.
The investigators expect little to no attrition bias since the intervention is simple with a short follow-up. The investigators expect some missing data for duration of the motor block, as most participants will have the affected limb immobilized post-surgery, thereby making assessment of return of motor function difficult.
The investigators pre-defined the statistical analysis plan prior to unblinded data becoming available. The analysis plan can be found on: https://doi.org/10.6084/m9.figshare.22491214.
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
The trial medication was produced by Glostrup Pharmacy. The trial medication is produced as identically appearing opaque capsules containing either dexamethasone or placebo. The trial medication is stored in sequentially numbered containers that will be allocated to each participant as they enter the trial. All involved in the trial will be masked to treatment allocation until the final statistical analysis has been agreed upon by the steering committee.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for unilateral osseous surgery of the hand or forearm.
- •Anaesthesia with an infraclavicular brachial plexus block
- •Age of 18 or above
- •American Society of Anaesthesiologists Physical Status Score of 1 to 3
- •Body Mass Index of 18 to 40, but a minimum weight of 50 kg.
- •For fertile women, negative urine humane choriongonadotropine test and use of safe anti-conception
- •Ability to understand the trial protocol, risks and benefits, and provide signed informed consent
排除标准
- •Inability to read and understand Danish
- •Uncooperativeness (as judged by investigators)
- •Participation in another trial involving medication
- •Allergy to study medication
- •Daily use of opioids above 30 mg/day morphine (or equivalents)
- •Daily use of corticosteroids of more than 5 mg prednisolone equivalents within the past one month
- •Neurological or musculoskeletal disease making block performance impossible (as judged by investigators)
- •Dysregulated diabetes (as judged by investigators)
- •Dysregulated anti-coagulants (as judged by investigators)
- •History of drug or alcohol abuse
- •Contraindications for paracetamol or opioids
- •Other concomitant conditions needing surgery
- •Other concomitant traumatic injuries
研究组 & 干预措施
Placebo
Encapsulated glucosemonohydrate will be used as placebo. Two capsules containing placebo will be administered in the placebo arm.
干预措施: Placebo (Drug)
Dexamethasone 12 mg
Dexamethasone tablets of 4 mg encapsulated in pairs of three. One capsule containing 12 mg dexamethasone and one capsule containing placebo will be administered in the 12mg dexamethasone arm for a total dose of 12 mg of dexamethasone.
干预措施: Dexamethasone 12 mg (Drug)
Dexamethasone 24 mg
Dexamethasone tablets of 4 mg encapsulated in pairs of three. Two capsules containing 12 mg dexamethasone will be administered in the 25mg dexamethasone arm for a total dose of 24 mg of dexamethasone.
干预措施: Dexamethasone 24 mg (Drug)
结局指标
主要结局
Time to first pain (measured in minutes)
时间窗: 48 hours
Time to first pain will be recorded by the patient and measured as the time to first perceived pain in minutes in the surgical area. The patient will be asked to record the time and date of their first perceived pain in their trial log. This date and time will be compared to the date and time of the block performance as recorded in the electronic Case Report Form. In the event of the patient not experiencing any pain, the time to first pain will be set to 48 hours.
次要结局
- Duration of the motor block (measured in minutes)(48 hours)
- Quality of sleep (Numerical Rating Scale) postoperative night 2(48 hours)
- Proportion of participants with one or more serious adverse events.(30 days)
- Quality of sleep (Numerical Rating Scale) postoperative night 1(24 hours)
- Proportion of participants with one or more adverse events not considered to be serious(48 hours)