Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal- A Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Pain intensity during cervical cerclage removal
研究概览
简要总结
The goal of this clinical trial is to determine whether inhaled nitrous oxide can reduce pain and anxiety during cervical cerclage removal compared with standard care. Cervical cerclage removal is commonly performed in the outpatient setting during the third trimester of pregnancy and may be associated with discomfort and anxiety despite being a brief procedure.
The study will include pregnant women aged 18 years or older undergoing elective cervical cerclage removal at 36 weeks of gestation or later.
The main questions the study aims to answer are:
- Does inhaled nitrous oxide reduce pain during cervical cerclage removal?
- Does inhaled nitrous oxide reduce anxiety during the procedure?
- Does the use of nitrous oxide improve overall patient satisfaction during cerclage removal?
Researchers will compare women receiving inhaled nitrous oxide to those receiving standard care without analgesia, as routinely practiced in the participating institutions, in order to determine whether nitrous oxide improves pain control and patient experience during the procedure.
Participants will:
- Be randomly assigned to receive either inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) or standard care without analgesic treatment during cervical cerclage removal.
- Undergo the procedure according to routine clinical practice in the participating centers.
- Complete questionnaires assessing pain and anxiety, including a visual analog scale (VAS) for pain and the State-Trait Anxiety Inventory (STAI).
- Have routine clinical data recorded from their medical records, including maternal vital signs and any procedure-related side effects.
详细描述
Cervical insufficiency is a recognized risk factor for spontaneous preterm birth, which remains a major cause of perinatal morbidity and mortality worldwide. Cervical cerclage is an established intervention used in carefully selected patients to reduce the risk of preterm birth.
While cerclage placement is typically performed under anesthesia in the operating room, cerclage removal is usually carried out in the outpatient setting during the late third trimester of pregnancy. Despite being a brief procedure, many patients experience pain, discomfort, and anxiety during cerclage removal. Evidence regarding optimal pain management strategies for this procedure remains limited, and most patients currently undergo cerclage removal without analgesia.
Nitrous oxide (N₂O) is an inhaled gas with well-established analgesic and anxiolytic properties. It has a rapid onset and offset of action and a favorable safety profile. Nitrous oxide is widely used in obstetrics, particularly for labor analgesia, and has also been used for pain management during minor medical procedures. However, its use specifically for cervical cerclage removal has not been well studied.
This study is a multicenter randomized controlled trial designed to evaluate whether inhaled nitrous oxide reduces pain and anxiety during elective cervical cerclage removal. Participants will be randomly assigned in a 1:1 ratio to receive either inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) during the procedure or standard care without analgesic treatment, as routinely practiced in the participating institutions. Randomization will be stratified by site and implemented using sequentially numbered sealed envelopes opened immediately prior to the procedure.
All procedures will be performed according to routine clinical practice in the participating centers. Maternal and procedural data will be collected from medical records, including procedure duration, maternal vital signs, and any reported side effects such as nausea, dizziness, or headache. Pain intensity will be assessed using a 0-100 mm visual analog scale (VAS), and anxiety levels will be evaluated using the State-Trait Anxiety Inventory (STAI). Additional outcomes will include maternal heart rate during the procedure and patient satisfaction with the procedure.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Women at ≥34 weeks of gestation
- •Singleton or twin pregnancy
- •Ability to understand, sign informed consent, and complete questionnaires
排除标准
- •Triplet or higher-order pregnancy
- •Contraindications to nitrous oxide use
- •Fetal monitoring category 2 or higher
- •Maternal body temperature >38°C
- •Significant vaginal bleeding
- •Severe preeclampsia
- •Cerclage removal under general anesthesia
- •Language or cognitive barrier
- •Baseline pain >3 on VAS scale, prior to the procedure
研究组 & 干预措施
Inhaled Nitrous Oxide During Cervical Cerclage Removal
Participants in this arm will receive inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The equipment is identical to the device routinely used for labor analgesia in the participating institutions and will be operated and monitored by trained midwives experienced in nitrous oxide administration.
Continuous pulse oximetry monitoring will be initiated prior to gas administration. Nitrous oxide inhalation will begin following instruction from the performing physician, and the procedure will start approximately three minutes after inhalation begins once adequate analgesia and anxiolysis are achieved. After completion of the procedure, nitrous oxide will be discontinued and the patient will breathe room air. The patient will remain in bed for approximately 15 minutes with fetal monitoring to conf
干预措施: Inhaled nitrous oxide (Drug)
Standard Care Without Analgesia
Participants in this arm will undergo cervical cerclage removal without analgesia, in accordance with the standard practice across the participating institutions. The procedure will be performed in the outpatient setting following routine clinical protocols. Maternal vital signs and fetal status will be monitored according to standard clinical practice. No nitrous oxide or other analgesic intervention will be administered as part of the study protocol.
结局指标
主要结局
Pain intensity during cervical cerclage removal
时间窗: 3-5 minutes following completion of the procedure
Pain intensity will be assessed using a 0-100 mm visual analog scale (VAS). Participants will rate the level of pain experienced during the procedure 3-5 minutes after completion of the cerclage removal.
次要结局
- Difference between expected pain and experienced pain(Baseline (prior to procedure) and 3-5 minutes following completion of the procedure)
- Procedure duration(During procedure)
- Change in maternal heart rate during procedure(Baseline measurement prior to the procedure and continuous monitoring during the procedure)
- Change in anxiety level (STAI)(Baseline (before procedure) and 3-5 minutes after completion of the procedure)
- Patient satisfaction(3-5 minutes after completion of the procedure)
- Adverse events(During procedure)
- Conversion to neuraxial or general anesthesia(During the procedure)
- Physician-rated procedural difficulty(3-5 minutes following completion of the procedure)
研究者
Gil Friedman
Principal Investigator, OB-GYN Resident
Kaplan Medical Center