Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy: a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain visual analogue scale (VAS)
研究概览
简要总结
A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies.
详细描述
A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies. Primary Objective: To study the effect of a combined ketorolac and lidocaine paracervical block on procedure related pain with office hysteroscopy. Secondary Objectives: To study the effect of a combined ketorolac and lidocaine paracervical block on patient satisfaction and post procedure pain. To assess for major adverse events with the use of a combined ketorolac and lidocaine paracervical block for office hysteroscopy when compared with a standard lidocaine paracervical block. Primary Endpoint: Pain on a 100 mm visual analogue scale during cervical dilation. Secondary Endpoints: Pain on a 100 mm visual analogue scale during the paracervical block, during the office hysteroscopy, immediately after the hysteroscopy, and 30 minutes after the procedure. Other secondary endpoints include patient satisfaction, frequency of procedure termination, and adverse events. Patients assigned female at birth, booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates. Patients scheduled for office hysteroscopy through seeing a Gynecologist at either 5 E 98th Street Faculty Practice Associates or 1176 5th Avenue Gynecology Practice. 5 E 98th Street primarily cares for privately insured patients, while 1176 5th Avenue cares for a mix of privately insured as well as patients insured with Medicaid. Regardless of recruitment site, all office hysteroscopies will be performed at the 5 E 98th Street facility. A randomized controlled trial designed to investigate if ketorolac added to a paracervical block reduces procedure related pain. Patient will be randomized to a standard paracervical block versus a paracervical block with ketorolac added. The study will be conducted over two years. Patients will be followed for the duration of the two-year study period.
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
An assistant will be in charge of mixing either the intervention or control paracervical block. The physician performing the procedure and the patient will be blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients assigned female at birth,
- •booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates.
排除标准
- •Allergy to ketorolac or non-steroidal anti-inflammatory medications
- •Allergy to lidocaine
- •Presence of thrombocytopenia
- •Contraindications to lidocaine
- •History of gastritis or gastric ulcer
- •Acute renal failure or chronic renal disease
- •Chronic liver disease
- •History of bleeding diathesis
- •Long term narcotic use
研究组 & 干预措施
Lidocaine alone
Paracervical block will be performed with just lidocaine
干预措施: paracervical block (Procedure)
Lidocaine alone
Paracervical block will be performed with just lidocaine
干预措施: Lidocaine (Drug)
Lidocaine plus ketorolac
Paracervical block will be performed with lidocaine plus ketorolac
干预措施: paracervical block (Procedure)
Lidocaine plus ketorolac
Paracervical block will be performed with lidocaine plus ketorolac
干预措施: Lidocaine (Drug)
Lidocaine plus ketorolac
Paracervical block will be performed with lidocaine plus ketorolac
干预措施: ketorolac (Drug)
结局指标
主要结局
Pain visual analogue scale (VAS)
时间窗: during procedure (cervical dilation)
Pain as measured on a 100 mm visual analogue scale (VAS) with cervical dilation. Full scale scored from 0-100, higher score indicates more pain.
次要结局
- Pain visual analogue scale (VAS)(with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure)
- Patient Satisfaction(with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure)
- Frequency of procedure termination(with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure)
研究者
Charles Ascher-Walsh
Professor
Icahn School of Medicine at Mount Sinai
