Trigger-point Blockade in Persistent Pain After Laparoscopically Assisted Groin Hernia Repair
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Normalized summed pain intensity differences (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 laparoscopical groin hernia repair.
详细描述
This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after laparoscopically assisted groin hernia repair, 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.
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
- 否
入选标准
- •Patients with persistent pain (< 6 mo) after laparoscopical 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 writing or speech
- •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
Active drug
10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord
干预措施: Bupivacaine (Drug)
Placebo
10 ml of normal saline deposited by ultra-sound guidance around the spermatic cord
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Normalized summed pain intensity differences (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)
- Thermal thresholds(20 min)
- Sensory mapping(20 min)
- Pain questionnaire(7 days)
- Sleep quality questionnaire(7 days)
研究者
mads u werner
MD, DMSc
University of Copenhagen