Preoperative Analgesia by Infiltration of the Pudendal Nerve Prior to Sacrospinous Ligament Suspension: The PAIN-S Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post-operative Pain Score
研究概览
简要总结
Pelvic organ prolapse is a common problem. It affects about half of women and causes uncomfortable bulge sensations (similar to sitting on a ball), urine and stool problems, difficulty with sexual activity and embarrassment. Almost one of every five women undergoes surgery to treat prolapse.Typically, vaginal surgery is done while patients are asleep and local anesthetic- freezing medication- is injected where incisions are made to minimize the pain from surgery when waking up.
Pudendal blocks are nerve blocks where local anesthetic is used to freeze a nerve that supplies sensation to the vulva and vaginal area. It is traditionally used to help with pain for women giving birth, but hasn't been studied well in women undergoing vaginal surgery for prolapse.
The investigators believe that by using a small amount of freezing to provide a pudendal block at the time of surgery, on top of the freezing typically provided, that there will be minimized pain after surgery and improve the recovery process. Based on previous studies using pudendal blocks for different vulvar and vaginal procedures, the investigators believe this to be a safe and potentially beneficial practice.
The investigators are planning to conduct a randomized controlled trial of 50 women. 25 will receive pudendal nerve blocks at the time of surgery, and 25 will receive placebo injections.The investigators will monitor their pain scores, satisfaction, use of pain medications and return to activities in order to determine if our intervention has caused a significant improvement in recovery.
详细描述
Study Procedures:
Randomization and Blinding:
Women will be randomized to receive either Bupivacaine 0.25% or Normal Saline pudendal injections based on the label within a sealed envelope randomly selected on the day of their surgery. Fifty labels will be created with twenty-five labels each of "Bupivacaine 20ml" or "Normal Saline 20ml" written on them. These will be placed in blank, identical envelopes and sealed and shuffled prior to the start of the study. Upon selection, the sealed envelope will be given to the circulating nurse who will draw up the selected solution and label it "pudendal block". The circulating nurse will be directed to not disclose the contents of the envelope or syringe to the participant or to any other member of the team. They will then re-seal the envelope with tape, place a patient label on it and return it to the surgical team post procedure to be returned to a locked file cabinet within the surgical office at the end of the day, to be kept securely with medical records. Group allocation envelopes will be opened after the collection of all outcome data is complete to allow for data analysis. In order to avoid local anesthetic toxicity, any calculations for other anesthetic agents utilized for the surgical procedure or anesthetic will assume that 20 ml of 0.25% Bupivacaine was administered. In the event that an emergent adverse complication is identified which may be attributable to the administered agent, the treatment allocation can be unblinded if this is deemed clinically necessary by the investigator or other treating physician. In the event this is required, the patient will be withdrawn from the study and excluded from the final analysis, but such case(s) will be described in the final study results.
The circulating nurse already draws up local anesthetic and normal saline as a routine part of this procedure for use in other ways, and so the investigators do not anticipate that their participation in this study will be a large burden of work. The investigators estimate that it will add no more than 2 minutes to their preparation time for the surgery.
Pudendal Block administration:
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, Care Provider)
盲法说明
Patients are surgeons are blinded to the contents of the injections (either local anesthetic or saline). Allocations will be revealed after all data is collected at the time of data analysis.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age
- •Diagnosed with prolapse and planning to undergo vaginal day surgery as treatment.
- •Must be undergoing a sacrospinous ligament fixation as part of their procedure. Those undergoing a concurrent anterior and/or posterior vaginal repair, or mid-urethral sling will also be included.
- •Able to read and write in English
- •Able to complete email surveys for the first 2 weeks after surgery
排除标准
- •Those with an allergy to local anesthetic (freezing injections)
- •Those who prefer to have surgery under spinal anesthesia
- •Those with planned concurrent vulvar, laparoscopic or abdominal surgery, or any planned concurrent vaginal surgery other than those in the inclusion criteria.
- •Those with a pre-existing chronic pain disorder requiring the regular use of opioid analgesics (more than twice weekly)
- •Those with a history of substance abuse
- •Those with a history of bleeding disorder
- •Those who would prefer not to participate in the study,
- •If unable to receive emails in order to fill out the surveys.
- •Inability to provide informed consent
- •Currently enrolled in any other research study involving drugs or devices
研究组 & 干预措施
Pudendal nerve block
25 women will receive pudendal nerve blocks of 0.25% Bupivicaine 10ml administered vaginally prior to making any surgical incisions.
干预措施: Pudendal nerve block (Procedure)
Pudendal nerve block
25 women will receive pudendal nerve blocks of 0.25% Bupivicaine 10ml administered vaginally prior to making any surgical incisions.
干预措施: Bupivacaine Injectable Product (Drug)
Placebo
25 women will receive sham pudendal nerve blocks using normal saline. These will also be administed vaginally prior to making any surgical incisions.
干预措施: Sham Pudendal nerve block (Procedure)
结局指标
主要结局
Post-operative Pain Score
时间窗: measured at post-operative day 14
measured on a Visual Analog scale (1-10)
次要结局
- Readiness for discharge(measured at post-operative day 0 prior to discharge)
- Post-operative Analgesic use(measured at postoperative day 14)
- Patient satisfaction(measured at postoperative day 14)
- Functional Recovery Index(measured at postoperative day 14)
研究者
Sophia Badowski
Principal Investigator
Fraser Health