Balancing Analgesia and Side Effects: Intrathecal Fentanyl and Morphine Versus Fentanyl for Cesarean Section Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Assessing the perioperative analgesic efficacy
研究概览
简要总结
Intrathecal opioids are frequently combined with local anesthetics to optimize spinal anesthesia for cesarean delivery. Fentanyl, a lipophilic opioid, offers rapid onset and enhanced intraoperative analgesia. However, its postoperative analgesic duration is limited, but in contrast, morphine, a hydrophilic opioid, provides prolonged postoperative pain control but has a slower onset and a higher incidence of adverse effects, notably nausea and vomiting. This prospective, randomized, double-blind, parallel study enrolled 180 parturients scheduled for elective cesarean section, all receiving spinal anesthesia with hyperbaric bupivacaine (7.5-10 mg, adjusted to height) plus either intrathecal fentanyl 25 µg (F group) or intrathecal morphine 100 µg and fentanyl 25µg (M+F group). Primary outcomes include intraoperative and postoperative pain scores, systemic opioid consumption, and patient satisfaction, while secondary outcomes assess the incidence of opioid-related side effects.
详细描述
Eligible patients will be allocated in a 1:1 ratio into one of two groups:
Group F (Fentanyl): Hyperbaric bupivacaine 0.5% combined with fentanyl 25 µg. Group M+F (Morphine + Fentanyl): Hyperbaric bupivacaine 0.5% combined with morphine 100 µg and fentanyl 25 µg.
The dose of hyperbaric bupivacaine (7.5-11 mg) will be determined according to patient height. Randomization will be performed using the envelope technique. Two anesthetists will participate in each case: The first anesthetist will perform the spinal anesthesia and will remain blinded to the drug solution. The second anesthetist will open the allocation envelope, prepare the assigned intrathecal solution, and provide it to the first anesthetist. All drugs will be sourced from the same manufacturer to ensure uniformity.
During the pre-anesthetic visit, all patients will receive detailed information regarding the aims of the study, the planned anesthetic technique, the postoperative analgesia regimen, and the use of the Numeric Pain Rating Scale (NPS). Demographic and clinical data will be collected, including height, term weight, age, smoking status, obstetric history (gesta/para), presence of preoperative contractions, full medical history, current medications, and any allergies.
An 18G intravenous cannula will be inserted, and 500 mL of Ringer lactate will be infused prior to anesthesia. All participants will fast preoperatively and will receive pantoprazole 40 mg and metoclopramide 10 mg as premedication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •American Society of Anesthesiologists (ASA) physical status class I-II.
- •Absence of significant past medical conditions.
- •No documented hypersensitivity to any study drug.
- •No history of chronic pain syndromes or regular analgesic consumption.
- •No anxiety or depressive disorders diagnosis.
- •Body weight ≥ 50 kg.
- •Scheduled for elective cesarean delivery.
- •Single fetus.
排除标准
- •Patient refusal.
- •Contraindication of spinal anaesthesia.
- •Conversion from a natural delivery with or without an epidural anaesthesia started.
- •History of substance abuse or drug dependence.
- •Presence of acute or chronic fetal distress.
- •Preeclampsia.
- •Allergic reaction occurring after enrollment.
- •Refusal to receive protocol-specified analgesics or medications.
- •Requirement for surgical re-intervention within 72 hours postoperatively.
- •Previous administration of opioids or other central nervous system depressants prior to intervention.
研究组 & 干预措施
Fentanyl, Morphine and Bupivacaine
Pregnant patients scheduled for C-section that received a spinal anaesthesia mixture of Fentanyl, Morphine and Bupivacaine
干预措施: fentanyl + morphine (Drug)
Fentanyl and Bupivacaine
Pregnant patients scheduled for C-section that received a spinal anaesthesia mixture of Fentanyl and Bupivacaine
干预措施: fentanyl (Drug)
结局指标
主要结局
Assessing the perioperative analgesic efficacy
时间窗: 6 months
Pain intensity will be evaluated using the Numeric Pain Scale, with scores obtained at the time of skin incision, at the end of surgery, and at 4h, 6h, 12h, 24h, 48h, and 72 hours postoperatively; AUE72h (sum pain intensity differences area over 72 hours) and SPID72h (time-weighted sum pain intensity differences over 72 hours). Assessments will be conducted both at rest and during mobilization. The pain scores according to the Numeric Pain Scale will be rated between 0 and 10, meaning 0 - no pain and 10 - the worst pain imaginable
Assessing the degree of patient's satisfaction
时间窗: 6 months
Assessing the degree of satisfaction on a five point scale with the highest rate as being "completely satisfied", followed by "satisfied", "so so", "unsatisfied" and "completely unsatisfied"
次要结局
- Incidence of Additional Opioid-Related Adverse Effects(6 months)
- Incidence and Severity of Pruritus(6 months)