Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Level of Pain During Specific Time Intervals Throughout D&C Procedure.
研究概览
简要总结
The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize that women who receive a paracervical block of combined ketorolac and lidocaine will experience less pain during the procedure based on a visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a paracervical block with lidocaine alone.
This randomized, multi-site, placebo-controlled clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical block with lidocaine alone. A total of fifty women who are seeking elective surgical abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore, Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during, and after surgical abortion will be measured using a 100-mm VAS.
The primary outcome of interest is the mean difference in pain level from preoperative baseline to time after cervical dilation comparing the treatment groups. If the investigators see greater pain reduction associated with the paracervical block of lidocaine and ketorolac, adoption of this regimen may improve pain management during first trimester surgical abortions. If combined ketorolac and lidocaine when administered as a paracervical block is proven to be efficacious, the need for additional analgesia in first trimester surgical abortions can be minimized.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age greater than or equal to 18 years
- •English-speaking
- •ability and willingness to sign the informed consent
- •ability and willingness to comply with the terms of the study
- •voluntary request for pregnancy termination
- •ultrasound-confirmed singleton intrauterine pregnancy with an estimated gestational age not exceeding 76 days (10 6/7 weeks) from the first day of the preceding menstrual cycle
排除标准
- •women who require or request sedation
- •untreated acute cervicitis or pelvic inflammatory disease
- •contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria
- •allergic reaction or sensitivity to lorazepam or NSAIDs
- •chronic NSAID use
- •history of gastritis or gastric ulcer
- •acute renal failure or chronic renal disease
- •chronic liver disease
- •history of bleeding diathesis
- •chronic narcotic use
- •current or past history of illegal drug use (excluding marijuana)
研究组 & 干预措施
paracervical block with lidocaine
Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
干预措施: lidocaine (Drug)
paracervical block with ketorolac and lidocaine
Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
干预措施: ketorolac and lidocaine (Drug)
结局指标
主要结局
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
时间窗: Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure
100-mm Visual Analogue Scale (VAS) during specific time intervals of D\&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain) Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure.
次要结局
- Visual Analogue Scale Regarding Satisfaction Level(end of study (prior to clinic discharge))
- Reported Symptoms(end of study (upon discharge from facility after procedure))
- Complications(end of study)