Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Normalized summed pain intensity difference (SPID)
研究概览
简要总结
Groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life.
This study examines the effect of ultra-sound guided blocks with local anesthesia in the groin in regard to pain relief and sleep quality.
The hypothesis of the study is that a block will confer significant pain relief to patients with severe chronic pain following open groin hernia repair.
详细描述
This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after open groin hernia, examines the effect of an ultra-sound guided local anesthetic block of a trigger-point, situated near the spermatic cord at the superficial inguinal ring. In order to compare effects and distribution of the blocks in patients vs. healthy subjects, the block is tested and examined in volunteers using a similar methodology.
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)
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
- •Patients with persistent pain (< 6 mo) after open groin hernia repair
- •Patients with maximal pain area 3 cm or less from the superficial inguinal ring
- •Patients living in the Capital Region of Denmark (Region Hovedstaden) or the Region of Zealand (Region Sjælland)
排除标准
- •Known allergy to bupivacaine or other local anesthetics of amide-type
- •Declared incapable of making his/hers own affairs
- •Does not comprehend Danish in the written or spoken language
- •Cognitive impairment to a degree influencing the testing reliability
- •Known recurrence of the inguinal hernia
- •Other surgical procedures performed in the groin or on the external genitals
- •Neuropathy affecting the groin region caused by other conditions, e.g. post-stroke, multiple sclerosis, herniated intervertebral disc
- •Abuse of alcohol or drugs
- •Unable to cooperate with the sensory examinations
研究组 & 干预措施
Bupivacaine
injection, 25 mg, once, 5 min
干预措施: Bupivacaine (Drug)
Placebo
injection, 10 ml 0.9% sodium chloride, once, 5 min
干预措施: Placebo (Drug)
结局指标
主要结局
Normalized summed pain intensity difference (SPID)
时间窗: 20 min
The number of patients with normalized summed pain intensity differences (SPID) of more or equal to 50% after bupivacaine AND SPID less or equal to 25% after placebo.
次要结局
- Suprathreshold heat stimulation(20 min)
- Pressure pain thresholds(20 min)
- Pain questionnaire(7 days)
- Sleep quality(7 days)
- Thermal thresholds(20 min)
- Sensory mapping(20 min)
研究者
mads u werner
MD, MDSc
University of Copenhagen