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临床试验/NCT02502591
NCT02502591已完成2 期

Pudendal Nerve Block for Postoperative Pain Relief in Women Undergoing Posterior Vaginal Repairs: a Pilot Study

Royal Devon and Exeter NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
21
试验地点
1
主要终点
Post- op pain scores. as defined by VAS measure

研究概览

简要总结

Rectocoele or a posterior vaginal prolapse (bulge in the vagina) is a frequent gynaecological condition. It is repaired by repairing and reinforcing the support to the vaginal wall at the back. A small cut is made through the lining of the back wall of the vagina. The supports to the rectum are reinforced with stitches and the bulging part of the vaginal wall cut away. The wound in the vagina is then stitched up. Rectocoele repair is usually carried under a general anaesthetic with women reporting moderate to severe degrees of pain post operatively on sitting down.

A Pudendal Nerve Block (PNB) is a common analgesic (pain killing) technique often used for women who need an instrumental delivery during childbirth. It is also widely used during a range of surgical procedures (operations) as a preventive analgesia to help reducing post -operative pain. The investigators would like to see if using this technique during routine rectocele repair will help with post - op pain.

详细描述

Pelvic Organ Prolapse (POP) can occur in up to 50% of women after childbirth. Common complications include urinary infection, postoperative pain, and wound infection.

The majority of prolapse repair procedures are carried out under general anaesthetic (GA) with regular analgesia required post operatively. The pain is often described as "agonizing" and results in a substantial consumption of analgesia, often leading to extended periods of bladder catheterisation and bowel dysfunction. Despite numerous attempts to modify surgical techniques and anaesthetic regimens, the problems persist.

In an attempt to relieve the problem local clinicians have had promising results from the addition of a standardised preventive Pudendal Nerve Block (PNB) in reducing post- op pain. To widen the clinical utility of this procedure an evidence base will be required.

Preventive analgesia: Preventive analgesia is a broad term used to describe an analgesic regime given during surgery to control post - op pain and its aim is to reduce the impact of the process known as central sensitization. This refers to an increase in synaptic efficacy in the somatosensory neurons following tissue injury (e.g. surgery) or nerve damage. This leads to a reduction in pain threshold, an amplification of pain responses and a spread of pain sensitivity to non-injured areas resulting in increased post -op pain intensity and analgesic requirements. Preventive analgesics (including nerve blocks) have been incorporated into a range of surgical procedures, with a recent review identifying its strong positive impact on post-operative pain and analgesic consumption.

The Pudendal nerve is a mixed nerve (sensory and motor) derived from the somatic component of sacral nerve roots S2-S4. It is located behind the sacrospinous ligament. It supplies anal and urethral sphincters, the pelvic floor muscles, anal and perineal skin. PNB is a routine procedure used during instrumental deliveries in obstetrics and as a low-risk, low-cost anaesthetic technique effectively reducing perineal and vaginal discomfort during repair of obstetric lacerations. PNB is also increasingly being utilised as a preventive analgesia with positive results on pain relief, reduced analgesics, improved spontaneous micturition, less pain on defecation and shorter hospital stay and pain on following haemorrhoidectomy. Improving post- operative pain relief and enhancing patient recovery is of fundamental importance to both the individual and the National Health Service (NHS). This study is a preliminary step in the assessment of a preventive analgesia on women's post- op experience following routine posterior vaginal wall surgery.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing isolated posterior vaginal wall repair under GA
  • Age 20-80 yrs
  • Wiling and able to provide informed consent

排除标准

  • Women undergoing concomitant anterior repairs, vaginal hysterectomies or mesh repair
  • History of chronic pelvic pain.
  • Known allergy to local anaesthetic agents
  • Unable/unwilling to provided informed consent

研究组 & 干预措施

intervention

Experimental

Additional pain relief (a Pudendal Nerve Block (PNB)) will be administered during surgery in addition to routine care.

干预措施: Pudendal Nerve Block (Drug)

结局指标

主要结局

Post- op pain scores. as defined by VAS measure

时间窗: over a 48 hour post-operative period.

Pain score defined by Visual Analogue Scores (VAS)

次要结局

未报告次要终点

研究者

发起方
Royal Devon and Exeter NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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