To evaluate the minimum effective dose of epidural levobupivacaine with fentanyl for pain relief in labour after combined spinal epidural labour analgesia

To evaluate and compare epidural minimum local analgesic concentration of levobupivacaine with fentanyl in patients receiving intrathecal fentanyl with and without levobupivacaine for labour analgesia - NA

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009542

Enrollment

Registered

2017-08-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Primigravida women requesting labour analgesia with full term gestation 36-40 weeks, singleton pregnancy with cephalic presentation having American Society Of Anesthesiologists physical status II

Interventions

Intervention1: Intrathecal levobupivacaine 2.5mg and fentanyl25mcg: Minimum epidural local analgesic concentration of levobupivacaine and fentanyl after intrathecal levobupivacaine and fentanyl star

Eligibility

Inclusion criteria

Inclusion criteria: 1.Primigravida women requesting labour analgesia with full term gestation 36-40 weeks, singleton pregnancy with cephalic presentation having American Society Of Anesthesiologists physical status II 2.Patients giving valid informed consent. 3.Patients in active stage of induced labour with cervical dilatation of 4-5 cm at the time of epidural catheter placement

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Gestational age >36 weeks with malpresentation/ multiple gestation. 3. Patients with PIH / Eclampsia. 4. Patients who have received IV/ IM opioids within 4 hours of epidural insertion. 5. Entered in second stage of labour. 6. Delivery within 30mins of intrathecal analgesia. 7. Delivery without the requirement of epidural top up. 8. Failure to obtain VAS 9. Patient with motor block higher than T4 dermatomal level at any time post procedure suspecting intrathecal epidural catheter insertion. 10. Inadvertent dural puncture during epidural space localization. 11. Patients with contraindication to regional analgesia

Design outcomes

Primary

Measure	Time frame
To evaluate and compare epidural minimum local analgesic concentration of levobupivacaine with fentanyl in patients receiving intrathecal fentanyl with and without levobupivacaine for labour analgesiaTimepoint: During labour analgesia	—

Secondary

Measure	Time frame
Duration of intrathecal analgesia quality of analgesia haemodynamic monitoring maternal and neonatal outcomeTimepoint: During labour analgesia	—

Countries

India

Contacts

Public ContactHema Solanki

Dr L H Hiranandani Hospital

meenoti@yahoo.com9920627839

Outcome results

None listed

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