The Influence of Different Doses of Local Anesthetic on the Distribution of Anesthesia of the Lateral Femoral Cutaneous Nerve - a Randomized, Blinded, Paired Study of Healthy Individuals
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in the percentage coverage of the incision (posterior approach) assessed by cold sensation with an alcohol swab.
研究概览
简要总结
The purpose of this study is to investigate and describe the anatomical differences in distribution of the blocked area following a perineural LFCN (Lateral Femoris Cutaneous Nerve) block with either 8 ml or 16 ml of Ropivacaine, in relation to incision lines used in THA (Total Hip Arthroplasty). Furthermore, we examine any loss of motor function in Musculus Quadriceps due to posible involvement of the Femoral Nerve. This trial will be conducted in healthy volunteers, as a blinded, randomized, paired trial.
详细描述
Background:
Total hip arthroplasties may be associated with moderate to intense postoperative pain. It is essential that pain treatment, besides being analgesic, has a minimum of side effects, especially those opioid-related, in order to achieve low morbidity, high patient satisfaction and to encourage the functional rehabilitation.
Currently, there is no "gold standard" for pain treatment after THA, and there exists a large variety of treatment options. Some patients who have undergone THA, can be difficult to sufficiently treat with conventional analgesics without reaching additional morphine doses where side effects are unacceptable. It is therefore important to explore other treatment options, including nerve blockade.
Nerve blocks have previously been used after THA operations, but have been hampered by the fact, that the nerve blocks have an effect on the motorial nerve, inhibiting early mobilization and possibly increasing tendencies to fall when mobilized. The Lateral Femoral Cutaneous Nerve (LFCN) is purely sensorial and can therefore relieve the patient of pain without influencing the early mobilization.
In two previous trials, the investigators have studied the effect of LFCN blocks in pain treatment after THA. In the recent study, the LFCN block was applied in patients after THA, who still had visual analogue scale (VAS) mobilization pain > 40 mm when lifting their leg stretched. The LFCN block alleviated significantly the average pain at group level. Meanwhile 42% of patients in the study had no or limited effect of the block. The reason for this may be due to the fact, that LFCN block does not cover all types of pain after THA, but also the fact, that the nerve innervation area has individual differences in the anatomical distribution. We are currently investigating this matter in another study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant who have given their written consent after understanding the content and limitations of the study.
- •BMI ≥ 18 or ≤ 30
排除标准
- •Participants who can not cooperate in the study.
- •Participants who can not speak or understand danish.
- •Allergies to the drugs used in the study.
- •Alcohol abuse, by the investigators judgement.
- •Drug abuse, by the investigators judgement.
- •Daily use of prescription required analgesic drugs within the last four weeks.
- •Consumption of over the counter analgesic drugs within the last 48 hours.
- •Neuromuscular defects, former surgery or trauma to the lower extremities. (Hip to knee)
- •Broken skin or wounds on the lower extremities, that could be hindering in the evaluation of the anatomical distribution of the LFCN block.
- •Diabetes Mellitus.
- •Pregnant women (women in the fertile age must be using safe contraception and produce a negative urine-HCG test to be able to participate in the study).
- •Large tattoos in the examination area.
研究组 & 干预措施
Low dose Ropivacaine
Perineural injection of 8 ml of Ropivacaine 0.75% at the lateral femoral cutaneous nerve
干预措施: Ropivacaine Injection (Drug)
High dose Ropivacaine
Perineural injection of 16 ml of Ropivacaine 0.75% at the lateral femoral cutaneous nerve.
干预措施: Ropivacaine Injection (Drug)
结局指标
主要结局
Difference in the percentage coverage of the incision (posterior approach) assessed by cold sensation with an alcohol swab.
时间窗: 1 hour post-block
Difference in the percentage coverage of the incision (posterior approach) between the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml, assessed by cold sensation with an alcohol swab.
次要结局
- Difference in the percentage coverage of the incision (anterolateral approach) assessed by cold sensation with an alcohol swab.(1 hour post-block)
- The percentage of patients with no sensory function assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (anterolateral approach)(1 hour post-block)
- Difference in the percentage coverage of the incision (posterior approach) assessed by pinprick (von frey).(1 hour post-block)
- Difference in the percentage coverage of the incision (anterolateral approach) assessed by pinprick (von frey).(1 hour post-block)
- The percentage of patients with no sensory function assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach)(1 hour post-block)
- The difference in MVIC of the knee joint(1 hour post-block)
- The percentage of patients with no sensory function assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach)(1 hour post-block)
- The percentage of patients with no sensory function assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (anterolateral approach)(1 hour post-block)
- Estimation of the areal of the sensory loss(1 hour post-block)