FUndal Block During NovaSure enDometrial AbLation to Reduce Intraoperative PAIN: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Intraoperative pain
研究概览
简要总结
The objective of this study is to assess the efficacy of a fundal block in reducing women's perception of pain during NovaSure endometrial ablation (EA) in an outpatient-based setting.
详细描述
The researchers aim to determine whether participants receiving the paracervical and fundal block (experimental group) achieve clinically and statistically significant reductions in self-reported pain during NovaSure EA, as compared to those receiving paracervical block (control group). All women will obtain concurrent procedural sedation. Women's perception of pain will be recorded on a scale from 0 to 10 using the visual analogue scale (VAS).
The researchers hypothesize that the participants receiving combined paracervical and fundal block will experience less pain during the active procedure, as compared to those receiving paracervical block alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patient (participant), physician (care provider), recovery nurse (outcomes assessor) and researcher team (investigator) will all be blinded to the intervention. Only the assisting nurse dedicated to procedural setup will be aware of the allocated intervention.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Abnormal uterine bleeding
- •Pre-menopausal as determined by the presence of menstrual cycles
- •Must have completed their family or have no desire to preserve fertility
- •Uterus and cervix must meet eligibility criteria; based on hysteroscopy exam performed by the physician prior to the ablation procedure
- •Must be a female participant 25-55 years of age
排除标准
- •Any uterine characteristics that preclude performing EA
- •Past allergic reactions to local anaesthetic
- •Weight <50kg
- •Submucous fibroids requiring myomectomy
- •Lack of patient consent
研究组 & 干预措施
Treatment Group
NovaSure EA with an injection of local anaesthetic into the fundus. Paracervical block and procedural sedation as per usual.
干预措施: Xylocaine 1 % and Normal Saline (Drug)
Control Group
NovaSure EA with an injection of normal saline into the fundus. Paracervical block and procedural sedation as per usual.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Intraoperative pain
时间窗: 30 seconds into active ablation procedure
Thirty seconds into the active NovaSure EA procedure, all participants will be asked the same standardized question to rate their pain. The question will be posed by the registered nurse assisting the physician, and the women will score their perception of pain on a scale from 0 to 10 using the VAS.
次要结局
- Rescue analgesics/and or sedation(From time of active ablation procedure to discharge from unit (t = 0 sec to t = ~3hrs).)
- Acceptability of the procedure(Post-procedure prior to discharge (t = ~3hrs).)
- Post-operative pain(1 hour post-procedure)
- Adverse reactions(From time of active ablation to discharge from unit ( t= 0 sec to t = ~3hrs).)
研究者
Darrien Rattray
Principal Investigator, Clinical Associate Professor, Department of Obstetrics and Gynecology
Saskatchewan Health Authority - Regina Area