Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of Participants With Response to Occipital Nerve Block in Pregnancy
研究概览
简要总结
This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.
详细描述
This is an open label randomized controlled trial. Women who present to the MEU with headache will be assessed by trained nurse practitioners and/or OB/GYN residents. If the woman meets criteria for the study she will be enrolled by an MEU provider doing the primary assessment.
See Figure 1 for the flow diagram depicting the patient's course through MEU. If eligible for inclusion, women will be randomly assigned to ONB or headache cocktail. Randomization will occur at time of enrollment. Prior to headache treatment 10-point visual/verbal rating scale (VRS) will be obtained. Treatment time is defined as time the patient takes the medication or the time that the needle is inserted into the greater occipital notch. At 60 min after treatment VRS will again be obtained by nursing staff or primary provider. If headache pain is resolved, defined as a VRS 0, the patient will be discharged to home (at the discretion of the managing team providing there are no other indications for further observation or admission). If pain continues to be present VRS will again be assessed at 120 min after treatment. If pain is not improved to mild range, defined as a VRS ≤ 3, or resolved, crossover treatment will be given. VRS will be obtained at 60 min after cross over treatment; if pain is resolved patient will be discharge to home. If pain continues to be present VRS will be obtained at 120 min after cross over treatment. If pain is not improved to mild pain or resolved; second line treatment of Promethazine 25mg/Benadryl 25mg will be given. VRS will again be obtained 60 min after second line treatment. If pain is not improved to mild pain (VRS ≤3) or resolved neurology consult will be considered. If at any point during treatment the patient develops new neurological symptoms study protocol will be stopped and neurology will be consulted.
Patients will be called 7 days after discharge to access short term outcomes (headache frequency since MEU visit, injection site complications, and satisfaction with treatment.) Patients will again be called at 28 days and a chart abstraction will be done to access for long term outcomes (recurrent presentation for headache to the MEU, maternal complications including preeclampsia, or fetal complications).
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Occipital Nerve block
- Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks.
- Site of injection will be cleaned with an alcohol swab.
- 5cc of 0.5% bupivacaine will be injected into both right and left occipital nerves using a 2.5 inch 25 gauge needle. The needle will be changed between injecting sites.
- After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
干预措施: Occipital Nerve Block (Drug)
Oral Acetaminophen/Caffeine Group
Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)
干预措施: Occipital Nerve Block (Drug)
结局指标
主要结局
Number of Participants With Response to Occipital Nerve Block in Pregnancy
时间窗: 60-300 min
Based on guidelines from the International Headache Society the primary outcome is the portion of women who experience resolution of headache or improvement of headache to mild range (VRS ≤ 3) at 2 hours following treatment with Occipital nerve block as compared to acetaminophen/caffeine cocktail.
次要结局
- Response to Treatment Within 2 Hours(2 hrs)
- Response to Second Line Treatment at 60 Min(180min)
- Number of Participants With Need for Admission for Treatment of Headache(7 hours)
- Response to Cross Over Treatment at 60 Min(60 min)
- Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days(7 days)
- Number of Participants With Satisfaction of Response Treatment at 7 Days(7 days)
- Number of Participants With Need for Crossover Treatment(4 hours)
- Number of Participants With Need for Second Line Treatment(120 min)
- Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days(28 days)
- Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)(7 days)
- Number of Participants With Need for Neurology Consult(5 hours)
- Number of Participants With Need for Representation for Treatment of Headache With 28 Days(28 days)
- Duration of Headache Free Period at 7 Days(7 days)
研究者
Rachel Sinkey
Assistant Professor
University of Alabama at Birmingham