evaluate the safety and effectiveness of Fixed Dose Combinations of Bupivacaine and Fentanyl epidural injection in post-operative and labour pai
- Conditions
- Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2020/07/026903
- Lead Sponsor
- Troikaa Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method