Clinical trial
Comparison Between Hyperbaric Bupivacaine With Fentanyl vs. Hyperbaric Bupivacaine With Dexmedetomidine in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anaesthesia: A Prospective Randomised Double-Blind Study
Name
98-2024
Description
In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale
Trial arms
Trial start
2024-04-01
Estimated PCD
2024-08-01
Trial end
2024-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine
In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale.
Arms:
Bupivacaine with Dexmedetomidine (BD), Bupivacaine with Fentanyl (BF)
Size
168
Primary endpoint
Primary outcome
Intraoperative
Eligibility criteria
Inclusion Criteria:
* Elective caesarean deliveries under SAB
* ASA PS II
* Age ≥18 years
* Term pregnancy ≥37 weeks of gestation
* Height ≥ 150
Exclusion Criteria:
* Patients with medical disorder in pregnancy (neurological, psychiatric, cardiopulmonary,
* hepatorenal diseases, coagulopathy)
* Patient refusal to participate
* Allergy or hypersensitivity to LA, fentanyl or dexmedetomidine
* Patients with communication problem
* Patient with bradycardia (HR- less than 60)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Research method: Quantitative Type of study: Randomized, interventional, comparative study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 168, 'type': 'ESTIMATED'}}
Updated at
2024-04-24
1 organization
1 product
1 indication
Indication
Visceral Pain