The Impact of a Shared Decision-Making Intervention on Intraoperative Patient Experience During Elective Cesarean Delivery Under Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary outcome will be the incidence and severity of pain during cesarean delivery, defined as an NRS score ≥4 at any intraoperative time point.
研究概览
简要总结
Caesarean delivery (CD) is a common surgical procedure performed when vaginal delivery poses risks to the mother or fetus, with global rates projected to reach 28.5% by 2030. Neuraxial anesthesia is the preferred technique due to its safety advantages over general anesthesia, which is associated with increased risks such as impaired oxygenation, aspiration, and higher incidence of postpartum depression. Although spinal anesthesia is widely used, it may be complicated by intraoperative pain during cesarean delivery (PDCD), attributed to visceral traction despite adequate sensory block . PDCD is associated with adverse psychological outcomes including anxiety, postpartum depression, and post-traumatic stress disorder , and is the leading cause of obstetric anesthesia-related medicolegal claims in the United Kingdom . Reported incidence rates vary widely, from 2.1% to 36%, reflecting under-recognition and misinterpretation by clinicians who may mistake pain for anxiety . Shared decision-making (SDM) is a patient-centered approach that incorporates patient preferences into perioperative planning and has been shown to improve outcomes in various surgical settings , yet its impact on intraoperative experience during cesarean delivery remains unexplored.
详细描述
All participants will receive spinal anesthesia in the sitting position at either the L3-L4 or L4-L5 interspace using 0.5% hyperbaric bupivacaine (dose adjusted by patient height) combined with fentanyl 15 mcg. Surgery will commence only after confirmation of a bilateral sensory block to at least the T5 dermatome and motor block. Standard monitoring will be applied continuously throughout the procedure, including ECG, heart rate, noninvasive blood pressure, and pulse oximetry. A preload of 500 mL lactated Ringer's solution will be administered. Intraoperative hypotension, bradycardia, nausea, and respiratory depression will be treated according to institutional protocols. Postoperative pain will be managed using paracetamol and ketorolac, with intravenous morphine administered as rescue analgesia for NRS ≥4.
Intervention Protocol Control Group (Standard Care) Patients will receive standard preoperative counseling delivered by the anesthesiologist using the institutional script. No structured shared decision-making process or documented preference for intraoperative analgesic management will be included.
SDM Group (Structured Intervention)
Patients randomized to the SDM group will participate in a structured 10-15 minute shared decision-making session, based on the Elwyn three-step model(8) (choice talk, option talk, decision talk), supported by an Arabic Option Grid™. Patients will be presented with two intraoperative comfort management options:
Proactive Plan: prophylactic IV ketamine 0.2 mg/kg or IV midazolam 1 mg given prior to incision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •pregnant women aged 18 years or older, with a singleton pregnancy
- •scheduled for elective cesarean delivery under spinal anesthesia
- •classified as ASA physical status I or II, and fluent in Arabic.
排除标准
- •refusal to participate; contraindications to spinal anesthesia (such as coagulopathy, infection at the injection site, or severe hypovolemia)
- •emergency cesarean procedures
- •cognitive impairment
- •history of chronic pain disorders
- •regular preoperative analgesic use
- •conversion to general anesthesia.
研究组 & 干预措施
Control Group (Standard Care)
Patients will receive standard preoperative counseling delivered by the anesthesiologist using the institutional script. No structured shared decision-making process or documented preference for intraoperative analgesic management will be included.
干预措施: Control Group (Standard Care) (Other)
SDM Group (Structured Intervention)
Patients randomized to the SDM group will participate in a structured 10-15 minute shared decision-making session, based on the Elwyn three-step model(8) (choice talk, option talk, decision talk), supported by an Arabic Option Grid™. Patients will be presented with two intraoperative comfort management options:
Proactive Plan: prophylactic IV ketamine 0.2 mg/kg or IV midazolam 1 mg given prior to incision.
Reactive Plan: no prophylactic medication; rescue IV fentanyl 50 mcg administered only if NRS ≥4.
Proactive: administer the chosen medication prior to skin incision. Reactive: administer rescue analgesia only if pain is reported.
干预措施: Proactive Plan: prophylactic IV ketamine 0.2 mg/kg or IV midazolam 1 mg given prior to incision. Reactive Plan: no prophylactic medication; rescue IV fentanyl 50 mcg administered only if NRS ≥4. (Other)
结局指标
主要结局
The primary outcome will be the incidence and severity of pain during cesarean delivery, defined as an NRS score ≥4 at any intraoperative time point.
时间窗: any intraoperative time point.
The primary outcome will be the incidence and severity of pain during cesarean delivery, defined as an NRS score ≥4 at any intraoperative time point.
次要结局
未报告次要终点