Duration of Peripheral Nerve Blocks in Opioid Tolerant Individuals - A Volunteer Blinded Matched Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The difference in the duration of sensory block for a radial nerve block between opioid-tolerant and opioid-naive individuals.
研究概览
简要总结
Do peripheral nerve blocks work shorter if you are on opioids?
Background:
Peripheral nerve blocks effectively alleviate postoperative pain. Animal studies and human research indicate that opioid tolerance results in reduced effectiveness of local analgesics. This applies to both central nerve blockade and infiltration anaesthesia. The impact on peripheral nerve block in humans has not been evaluated. The aim of the study is to assess the onset time and duration of a radial nerve block in opioid tolerant individuals compared to opioid naive individuals. We hypothesise that peripheral nerve blocks cause shorter sensory and motor block in opioid-tolerant compared to opioid-naive counterparts.
Methods:
Twenty opioid-tolerant individuals will be matched by sex and age with opioid-naïve counterparts. Participants will undergo an ultrasound-guided radial nerve block. The onset time and duration of motor and sensory blockade will be tested and measured. The primary outcome is difference in duration of sensory nerve blockade between the two groups. The secondary outcomes include the onset time of sensory blockade, onset time of motor blockade, and difference in duration of motor nerve blockade.
Perspectives:
The data from this study will provide evidence for the duration of peripheral nerve block in opioid tolerant individuals and support if a specific postoperative protocol for opioid tolerant individuals is needed or it should be of special attention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
An investigator blinded to the volunteer's opioid status will perform all the sensory and motor tests after thorough instruction in this procedure. Only the primary investigator will have the knowledge of opioid status.
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for opioid group
- •Age > 18 years old
- •Chronic pain, defined as persisting pain for more than three months
- •Daily use of more than 60 mg of morphine equivalent in more than 7 days
- •Legally competent and able to give informed consent
- •Inclusion criteria for the opioid naive control group
- •Age > 18 years old
- •No use of opioids within 30 days prior to participation
- •Legally competent and able to give informed consent
排除标准
- •Age > 84 years old
- •Volunteers who cannot cooperate with the study
- •Volunteers who cannot understand or speak Danish
- •Allergy to the lidocaine or the preservatives used in the study
- •Alcohol or drug abuse other than opioids
- •Peripheral neuropathy at the upper limb non-dominant arm
- •Pathology or previous major surgery to the upper limb
- •Active signs of infection in the cutaneous area of injection
- •Pregnancy at the time of the trial
- •Partial or complete 2nd or 3rd degree atrioventricular heart block without a pacemaker
- •Severe liver disease
- •Severe kidney disease and reduced kidney function (eGFR below 30 mL/min)
- •Daily treatment with drugs that are structurally related to local analgesics or class IB antiarrhythmics, as the toxic effects are additive
- •Daily treatment with class III antiarrhythmics e.g., amiodarone.
研究组 & 干预措施
Opioid tolerant
Daily use of opioid of 60 mg or more
干预措施: Radial nerve block (Other)
Opioid naive
No use of opioids within the last 30 days
干预措施: Radial nerve block (Other)
结局指标
主要结局
The difference in the duration of sensory block for a radial nerve block between opioid-tolerant and opioid-naive individuals.
时间窗: Up to one hour after nerve block placement.
Following the injection of local anaesthetic, motor and sensory assessments will be conducted at 30-second intervals until complete sensory and motor blockade, respectively. These assessments will involve comparisons with the contralateral side. Sensory testing will be performed on the dorsal side of the 1. intermetacarpal area (the space between the thumb and the index finger) and the proximal dorsolateral area of the antebrachium. In both areas seeking to explore the boundaries of the innervation area. Dual testing is performed to accommodate interindividual variabilities in dermatomes. Sensation will be evaluated with a monofilament (Touch Test, 60 g; Stoelting, Co, Wood Dale, IL) using a 11-point sensory scale: 5 = extremely intense sensation 0 = normal sensation. -5 = no sensation.
次要结局
- The difference in the onset time of sensory block from a radial nerve block between opioid-tolerant and opioid-naive individuals.(Up to one hour after nerve block placement.)
- The difference in the duration of motor block for a radial nerve block between opioid-tolerant and opioid-naive individuals.(Up to one hour after nerve block placement.)
- The difference in the onset time of motor block from a radial nerve block between opioid-tolerant and opioid-naive individuals.(Up to one hour after nerve block placement.)
研究者
Charlotte Runge
Senior Consultant
Regionshospitalet Silkeborg