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.