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临床试验/NCT02419443
NCT02419443Unknown4 期

The Impact of Perioperative Gabapentin on Chronic Groin Pain After Inguinal Hernia Repair

United States Naval Medical Center, San Diego0 个研究点目标入组 100 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
100
主要终点
Pain score

研究概览

简要总结

A common source of morbidity after IHR is chronic groin pain(CGP), usually defined as pain lasting longer than 3 months. Gabapentin is an anticonvulsant that is also of benefit in the treatment of neuropathic pain. We propose a randomized, double-blind, placebo controlled study of the effect of gabapentin on CGP after IHR. Their pain will be assessed with a visual analogue scale. For those reporting pain, the need for pain medication, or other treatment, and the effect of pain on their quality of life will be recorded.

详细描述

Over 500,000 inguinal hernia repairs(IHR) are performed in the United States annually. This is also one of the most common operations performed on the primarily young, male Active Duty population. A common source of morbidity after IHR is chronic groin pain(CGP), usually defined as pain lasting longer than 3 months. The incidence of CGP varies widely in published reports, but in the majority it is 25 to 30%. A major etiology of CGP is thought to be injury to inguinal nerves during surgery. Gabapentin is an anticonvulsant that is also of benefit in the treatment of neuropathic pain. Numerous studies have shown that gabapentin can decrease perioperative pain in patients undergoing surgeries such as hysterectomy, cholecystectomy and spine surgery. Doses and medication regimens varied in these studies, One study in patients undergoing IHR who received a single dose of gabapentin preoperatively, showed a decrease in postoperative pain and in reported pain scores in the first 6 months. We propose a randomized, double-blind, placebo controlled study of the effect of gabapentin on CGP after IHR. Patients will be given placebo or gabapentin. Those given gabapentin, will be given 300 mg orally three times daily for a total of six doses with the first dose given on the morning of surgery. Patients will be evaluated preoperatively and at 1, 6, 12 and 24 months after surgery. Their pain will be assessed with a visual analogue scale. For those reporting pain, the need for pain medication, or other treatment, and the effect of pain on their quality of life will be recorded.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients 18 years of age or older undergoing initial inguinal (bilateral or unilateral) hernia repair by any method (i.e. laparoscopic or open surgery)

排除标准

  • Age less than 18 years of age, recurrent hernias, emergency operations, already taking gabapentin, allergy to gabapentin, pre-existing chronic pain or psychiatric disorder

研究组 & 干预措施

Placebo

Placebo Comparator

Patients randomized to the placebo-group were administered placebo-pills orally one hour prior to surgery, then three times a day for a maximum of 6 total doses.

干预措施: Placebo (Drug)

Gabapentin

Active Comparator

Patients randomized to the gabapentin-group were administered 300 mg orally one hour prior to surgery, then three times a day for a maximum of 6 total dose.

干预措施: Gabapentin (Drug)

结局指标

主要结局

Pain score

时间窗: 24 months

Visual analog scale

次要结局

  • Quality-of-life (QOL)(24 months)

研究者

发起方
United States Naval Medical Center, San Diego
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Matthew Hannon

CDR

United States Naval Medical Center, San Diego

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