A Randomized Controlled Trial to Compare Between Hyperbaric Bupivacaine With and Without Fentanyl in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anaesthesia in Tribhuvan University Teaching Hospital

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Spinal anaesthesia with hyperbaric bupivacaine is the most commonly used anesthetic technique for cesarean section. Delivery of baby during cesarean section requires traction of peritoneum and handling of intraperitoneal organs resulting in intraoperative visceral pain. The incidence of this intraoperative visceral pain can be reduced with higher dose of hyperbaric bupivacaine (12-15mg), but increasing the dose of bupivacaine increases the risk of high sensory block resulting to major hemodynamic adverse events like hypotension, bradycardia or may lead to fetal distress. Neuraxial administration of fentanyl added to bupivacaine has been proposed to intensify the sensory block without increasing sympathetic block and also improves the quality of intraoperative analgesia thus, reduces the incidence of intraoperative visceral pain. Several studies have convincingly demonstrated efficacy of intrathecal fentanyl of different doses in improving the intraoperative analgesic effect along with its associated clinical effects. However, there has been limited research conducted to compare the analgesic effects of intrathecal fentanyl of low dose in reducing visceral pain in cesarean delivery especially in our setting. Therefore, in this study investigator aim to compare between hyperbaric bupivacaine alone with hyperbaric bupivacaine and fentanyl in reducing the visceral pain during cesarean sectionunder spinal anaesthesia. In this study, term parturient undergoing cesarean delivery in spinal anesthesia will be allocated in 2 groups. One group will receive intrathecal hyperbaric bupivacaine whereas another interventional group will receive hyperbaric bupivacaine with addition of fentanyl. Visceral pain will be assessed in both group using numerical pain rating scale along with monitoring of vitals. Data will be collected and will be filled up in a master chart in Microsoft Excel. Statistical analysis will be done.

2022-09-20

2023-04-13

2023-04-13

Completed

Early phase I

72

Inclusion Criteria: * ASA PS II * Elective cesarean deliveries under SAB * Age ≥18 years * Term pregnancy ≥37 weeks of gestation * Height ≥ 150 cm Exclusion Criteria: * Patients with neurological, psychiatric, cardiopulmonary, hepatorenal diseases, coagulopathy * Patient refusal to participate * Allergy or hypersensitivity to bupivacaine or fentanyl * Patients with communication problem

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to study where two groups of treatments B and BF are given so that one group receives only B while another group receives only BF for the duration of study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patients will be randomly distributed in the two groups using computed generated numbers that will be concealed in sequentially numbered, opaque sealed envelopes.\n\nThe envelopes will be opened by an attending nurse not involved in the study just before the procedure. The study drug will be prepared by the attending anesthesiologist/ resident who will perform the subarachnoid block. The assessment of pain and data collection, data analysis will be done by principle investigator who is blinded to procedure.\n\nThus, the patients and investigating and analyzing personal will be blinded to the procedure.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

2023-04-25