Post-operative Emesis and Pain Outcomes After Cesarean Delivery (EPOC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 595
- 试验地点
- 2
- 主要终点
- Postsurgical pain scores in both groups: Numeric Rating Scale
研究概览
简要总结
Approximately 20% women who undergo cesarean delivery would suffer from severe post-operative pain, which may further increase their risks from developing postpartum depression. Predictive factors such as pre-operative pain, age and anxiety could significantly contribute to post-operative nausea and vomiting (PONV) and pain in general surgery, however little information is available with regards to cesarean delivery. The investigators would investigate the risk factors of causing post-operative emesis after cesarean delivery, and to reaffirm that there is a positive correlation between pain on local anesthetic injection, presence of mechanical temporal summation (MTS) and post-Cesarean pain scores.
详细描述
Previous studies demonstrated that pain scores upon local anesthetic injection is positively correlated to post-cesarean pain scores. Anxiety, anticipated post-operative pain score and anticipated medication need are also found to be promising risk factors to post-cesarean pain management.
The investigators would investigate the risk factors of causing post-cesarean emesis, and to reaffirm that there is a positive correlation between pain on local anesthetic injection, presence of mechanical temporal summation (MTS) and post-Cesarean pain scores. 470 parturients undergoing cesarean delivery and requiring regional anaesthesia will be recruited. Pain and anxiety assessment will be conducted via visual analogue scoring (VAS), MTS assessment and a series of questionnaires. After delivery, patients will be given appropriate analgesia, and pain score at movement will be recorded. Secondary outcomes include pain scores at rest, analgesia consumption, time-to-first-rescue analgesia, opioid-related side effects, patient satisfaction and postpartum depression. A separate 125 patients will be recruited to evaluate the feasibility and patient acceptability of the use of Headspace, a mindfulness mobile application during the pre- and postnatal period to improve the maternal outcomes (emesis, pain, anxiety, depression).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant and going to have caesarean delivery (36 weeks gestation or more; nulliparous and multiparous);
- •Healthy or have mild medical problems that are well-controlled (American Society of Anesthesiologists physical status 1-2).
排除标准
- •History of intravenous drug or opioid abuse;
- •Previous history of chronic pain syndrome;
- •Emergency cesarean section;
- •Undergo general anaesthesia during cesarean delivery;
- •Non-English speaking.
研究组 & 干预措施
Control
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Patients will be assigned to this group when they have a pain score of less than 3 (out of 10) at 6-10 post-delivery online/phone survey.
干预措施: Mechanical Temporal Summation assessment (Procedure)
Control
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Patients will be assigned to this group when they have a pain score of less than 3 (out of 10) at 6-10 post-delivery online/phone survey.
干预措施: Preoperative pain assessment (Other)
Control
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Patients will be assigned to this group when they have a pain score of less than 3 (out of 10) at 6-10 post-delivery online/phone survey.
干预措施: Questionnaires (Other)
Postoperative pain
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Patients will be assigned to this group when they have a pain score of equal or more than 3 (out of 10) at 6-10 post-delivery online/phone survey.
干预措施: Mechanical Temporal Summation assessment (Procedure)
Postoperative pain
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Patients will be assigned to this group when they have a pain score of equal or more than 3 (out of 10) at 6-10 post-delivery online/phone survey.
干预措施: Preoperative pain assessment (Other)
Postoperative pain
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Patients will be assigned to this group when they have a pain score of equal or more than 3 (out of 10) at 6-10 post-delivery online/phone survey.
干预措施: Questionnaires (Other)
Control (non-Headspace)
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Twenty five patients will be assigned to this group when they agree to participate in a sub-study on the use of a mindfulness exercise mobile app (Headspace). Patients will have a follow-up online/phone call survey at day 7-20 and 4-8 weeks after delivery.
干预措施: Mechanical Temporal Summation assessment (Procedure)
Control (non-Headspace)
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Twenty five patients will be assigned to this group when they agree to participate in a sub-study on the use of a mindfulness exercise mobile app (Headspace). Patients will have a follow-up online/phone call survey at day 7-20 and 4-8 weeks after delivery.
干预措施: Preoperative pain assessment (Other)
Control (non-Headspace)
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Twenty five patients will be assigned to this group when they agree to participate in a sub-study on the use of a mindfulness exercise mobile app (Headspace). Patients will have a follow-up online/phone call survey at day 7-20 and 4-8 weeks after delivery.
干预措施: Questionnaires (Other)
Experimental (Headspace)
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Fifty five patients will be assigned to this group when they agree to participate in a sub-study on the use of a mindfulness exercise mobile app (Headspace). Patients will have a follow-up online/phone call survey at day 7-20 and 4-8 weeks after delivery.
干预措施: Mechanical Temporal Summation assessment (Procedure)
Experimental (Headspace)
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Fifty five patients will be assigned to this group when they agree to participate in a sub-study on the use of a mindfulness exercise mobile app (Headspace). Patients will have a follow-up online/phone call survey at day 7-20 and 4-8 weeks after delivery.
干预措施: Preoperative pain assessment (Other)
Experimental (Headspace)
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Fifty five patients will be assigned to this group when they agree to participate in a sub-study on the use of a mindfulness exercise mobile app (Headspace). Patients will have a follow-up online/phone call survey at day 7-20 and 4-8 weeks after delivery.
干预措施: Questionnaires (Other)
Experimental (Headspace)
Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Fifty five patients will be assigned to this group when they agree to participate in a sub-study on the use of a mindfulness exercise mobile app (Headspace). Patients will have a follow-up online/phone call survey at day 7-20 and 4-8 weeks after delivery.
干预措施: Headspace (Other)
结局指标
主要结局
Postsurgical pain scores in both groups: Numeric Rating Scale
时间窗: 6 -10 weeks after delivery
Pain scores (Numeric Rating Scale 0-10) at 6-10 weeks follow-up evaluations. Zero being no pain, and 10 being the worst pain possible.
次要结局
- Pain vulnerability in both groups: Pain Catastrophizing Scale(7 weeks (Upon recruitment until 5-14 days after delivery))
- Mechanical Temporal Summation as measured by von Frey filament in both groups(1 day (10 minutes))
- Edinburgh Postnatal Depression Scale (EPDS) before and after delivery(6 -10 weeks after delivery)
研究者
Sng Ban Leong
Principal Investigator
KK Women's and Children's Hospital