Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Pain at Time of Uterine Evacuation
研究概览
简要总结
This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.
详细描述
Project Summary
Justification for the project
One half of all pregnancies among American women are unintended, with nearly 4 in 10 ending in pregnancy termination by abortion. Elective abortions are among the most common outpatient surgical procedure, with an estimated 46 million performed worldwide annually. The management of pain is critical to patient care throughout the abortion experience since the vast majority of women will experience pain with the procedure. Patients are most affected by pain during paracervical block, cervical dilation, suction aspiration, and post operatively with uterine cramping. Innovation in pain control and reduction of anxiety, nausea and vomiting using a low cost, well-tolerated intervention could impact thousands of women each year.
Proposed research
This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Women >=18 years-old
- •Presenting for a surgical abortion
- •Fluency in English and able to provide informed consent
- •Has a driver to take them home following the procedure
排除标准
- •Allergy, sensitivity or contraindication to gabapentin
- •Severe renal disease
- •Currently using gabapentin or pregabalin
- •Contraindication to outpatient abortion under local anesthesia
研究组 & 干预措施
Gabapentin group
This group will receive local anesthesia per clinic protocol plus Gabapentin 600mg 1-2 hours preoperatively.
干预措施: Gabapentin (Drug)
Placebo group
This group will receive local anesthesia per clinic protocol plus placebo 1-2 hours preoperatively.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain at Time of Uterine Evacuation
时间窗: During the procedure on Study Day 1
The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100.
次要结局
- Perioperative Pain Level(Pre-procedure through post-procedure on Study Day 1)
- Moderate Pain at Postoperation Follow-up Assessment(Postoperative Day 1)
- Anxiety Levels(Pre-procedure through post-procedure on Study Day 1)
- Side Effects(10 and 30 minutes post procedure on Study Day 1)
- Vomiting Since Leaving Clinic(Postoperative Day 1)
- Number of Participants Using Pain Medication(Postoperative Day 1)
- Perioperative Nausea(Pre-procedure through post-procedure on Study Day 1)
- Perioperative Vomiting(Pre-procedure through post-procedure on Study Day 1)
- Severe Pain at Postoperation Follow-up Assessment(Postoperative Day 1)
- Nausea or Vomiting at Postoperation Follow-up Assessment(Postoperative Day 1)
- Overall Satisfaction With the Procedure(Postoperative Day 1)
研究者
Lisa Haddad
Associate Professor
Emory University