A prospective, open label, randomized, non-comparative, multicentric study to evaluate the safety and effectiveness of Fixed Dose Combinations of Bupivacaine and Fentanyl epidural injection in post-operative and labour pain

Troikaa Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•ASA Physical Status Class I or II
•Patients undergoing elective surgery with
•a. A plan to have epidural catheter for analgesia.
•b. If patients are female of childbearing potential: non-pregnant (supported by negative urine pregnancy test at screening), non-lactating and willing to maintain reliable birth control throughout the study
•Parturient in active labour with:
•a. A cervical dilation of 3–6 cm requesting epidural analgesia.
•b. Parturient having full-term live fetus, without any complications.

•Recent (within last 6 months) history of thromboembolic event e.g. Pulmonary embolism, deep vein thrombosis, superficial thrombophlebitis treated surgically
•Criteria includes multiple or preterm gestation pregnancies or weight >130 Kg
•Anticipated difficultly intubation
•Any contraindication for epidural catheter placement
•Hepatic impairment (SGPT/OT > 3 times ULN) or renal impairment (creatinine > 2 mg/dL)
•Known hypersensitivity to bupivacaine, fentanyl or diclofenac
•Presence of or susceptibility to respiratory depression
•Hypovolemia or complete heart block

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