Comparison Between Hyperbaric Bupivacaine with Fentanyl vs. Hyperbaric Bupivacaine with Dexmedetomidine in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anesthesia, A Prospective Randomized Double-Blind Comparative Study; Clinical Trial Protocol

Background Visceral pain during cesarean delivery under spinal anesthesia continues to pose a significant clinical challenge. This study aims to compare the effectiveness of intrathecal hyperbaric bupivacaine combined with fentanyl (Group BF) versus dexmedetomidine (Group BD) in mitigating intraoperative visceral pain. Methods A prospective, randomized, double-blind trial will enroll 116 ASA PS II & III parturients undergoing elective cesarean delivery. Participants will receive either 10mg hyperbaric bupivacaine + 10µg fentanyl (Group BF) or 10mg hyperbaric bupivacaine + 5µg dexmedetomidine (Group BD). Primary outcome: the frequency of intraoperative visceral pain during various stages of cesarean section. Secondary outcomes include hemodynamic stability, shivering, neonatal APGAR scores, and side effects such as nausea, vomiting, and pruritus. Discussion This study's findings will offer crucial insights into the impact of dexmedetomidine as the preferred adjuvant for spinal anesthesia during cesarean delivery. Potentially replacing opioids, it could reduce the incidence of opioid-related complications such as respiratory depression and pruritus, thereby enhancing recovery. This aligns with global initiatives aimed at optimizing perioperative outcomes through the adoption of non-opioid analgesia. Trial Registration: Registered at ClinicalTrials.gov (ID: NCT06367660 Trial Registration: ClinicalTrials.gov ID: NCT06367660