evaluate the safety and effectiveness of Fixed Dose Combinations of Bupivacaine and Fentanyl epidural injection in post-operative and labour pain

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026903

Enrollment

500

Registered

2020-07-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: fdc of Bupivacaine plus fentanyl citrate: Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2mcg/ml single dose via epidural route Bupivacaine Hydrochloride 1 mg/ml and Fentanyl

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Proportion of patients who required rescue analgesia Mean change in pain intensity on VAS at 30 and 45 minutes compared to baselineTimepoint: VAS at 30 and 45 minutes compared to baseline	—

Secondary

Measure	Time frame
Onset of analgesia Percentage of patients requiring rescue analgesia Change in pain intensity on VAS at 60, 120, 180 & 240 minutes compared to baseline Incidence of severe respiratory depression and discontinuation of study treatmentTimepoint: VAS at 60 120 180 and 240 min compared to baseline	—

Countries

India

Contacts

Public ContactPratik Shah

Troikaa Pharmaceuticals Limited

amitbhalla@troikaapharma.com07926856242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026