Comparison of hyperbaric bupivacaine with fentanyl vs. hyperbaric bupivacaine with dexmedetomidine in reducing visceral pain during cesarean delivery under spinal anesthesia: study protocol

The primary objective of this randomized, double-blind, parallel-group trial is to evaluate the efficacy and safety of intrathecal hyperbaric bupivacaine in conjunction with either fentanyl or dexmedetomidine in mitigating visceral pain during cesarean delivery. One hundred and sixteen parturients, classified as ASA II–III and scheduled for elective cesarean section, will be randomized 1:1 into two groups: Group BF will receive 10 mg hyperbaric bupivacaine in combination with 10 µg fentanyl. In contrast, Group BD will receive 10 mg hyperbaric bupivacaine in combination with 5 µg dexmedetomidine. The primary outcome is the frequency and intensity of visceral pain, assessed using an 11-point numerical rating scale at pivotal intraoperative stages. Secondary outcomes include hemodynamic stability, neonatal Apgar scores, shivering frequency, and the incidence of adverse effects. The primary hypothesis of this study is that dexmedetomidine may offer superior visceral pain control with a reduced incidence of adverse effects. Comparing Two Pain Relief Medicines Used in A cesarean birth (C-section) is often done under spinal anesthesia, which numbs the lower body, while the mother stays awake. While this works well for most women, some still feel uncomfortable or experience painful sensations in their belly during surgery, especially when the uterus is touched or moved. This kind of deep belly pain is called visceral pain. www.clinicaltrials.gov identifier is NCT06367660; Nepal Health Research Council (NHRC) Protocol ID: 98–2024. In this study, we are testing two medicines, fentanyl and dexmedetomidine, that can be added to spinal anesthesia to help reduce this type of pain. Fentanyl is a commonly used opioid, but it can cause side effects like nausea, itching, or drowsiness. Dexmedetomidine is a newer medicine that may give similar pain relief with fewer side effects. We will include 116 women who have planned cesarean births. Each woman will receive one of the two medicines and their spinal anesthetic. We will check how much pain they feel during key moments in the surgery. We will also watch for side effects, check the mother’s blood pressure and alertness, and assess the baby’s health right after birth. We aim to find out which medicine provides better pain relief during surgery while keeping both mother and baby safe and comfortable.

本研究标题为《剖宫产术中应用的两种镇痛药物对比》，其核心为一项随机双盲平行对照试验，主要目的为评估鞘内注射高压布比卡因（intrathecal hyperbaric bupivacaine）联合芬太尼（fentanyl）或右美托咪定（dexmedetomidine），用于剖宫产术中内脏痛缓解的有效性与安全性。本研究共纳入116例美国麻醉医师协会（American Society of Anesthesiologists, ASA）分级II~III级、拟行择期剖宫产术的产妇，按1:1比例随机分为两组：BF组予以10毫克高压布比卡因联合10微克芬太尼；BD组予以10毫克高压布比卡因联合5微克右美托咪定。本研究的主要结局为术中关键阶段采用11点数字评分量表（numerical rating scale, NRS）评估的内脏痛发生频率与强度。次要结局指标包括血流动力学稳定性、新生儿阿普加评分（Apgar scores）、寒战发生率及不良反应发生率。本研究的原假设为：右美托咪定可实现更优的内脏痛控制，且不良反应发生率更低。剖宫产术通常采用脊髓麻醉，可实现下半身躯体感觉阻滞且产妇保持清醒状态。尽管该麻醉方案对多数产妇效果良好，但部分产妇在术中仍会出现腹部不适或痛感，尤其当子宫被牵拉或移位时。此类深部腹部疼痛即定义为内脏痛。本临床试验的美国临床试验数据库（ClinicalTrials.gov）编号为NCT06367660；尼泊尔卫生研究委员会（Nepal Health Research Council, NHRC）方案编号：98–2024。本研究拟对两种可添加至脊髓麻醉中以缓解此类内脏痛的药物开展对比研究：芬太尼为临床常用阿片类镇痛药物，但可引发恶心、皮肤瘙痒、嗜睡等不良反应；右美托咪定作为新型镇痛辅助药物，或可提供同等镇痛效果且不良反应更少。本研究将纳入116例计划行剖宫产术的产妇，每名产妇将被分配接受两种试验药物之一联合脊髓麻醉。研究人员将在术中关键节点评估产妇的疼痛程度，同时监测产妇的血流动力学状态与意识水平、记录不良反应发生情况，并在产后即刻评估新生儿健康状况。本研究旨在明确哪种试验药物可在剖宫产术中提供更优的内脏痛缓解效果，同时保障母婴的安全与舒适。