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

Comparative Study Of Epidural Dose Requirement In Patients Receiving Intrathecal Fentanyl With And Without Levobupivacaine In Combined Spinal Epidural For Labour Analgesia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009624
Enrollment
120
Registered
2017-09-04
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 full term (37-40weeks) in active labour with ASA I and II

Interventions

Intervention1: Levobupivacaine, Fentanyl: CSE analgesia was administered under all aseptic precaution in the sitting position in the L3-4 or L2-3 intervertebral space. After identifying the space a lo

Sponsors

Dr L H Hiranadani Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA I & II Primigravida with singleton full term pregnancy with vertex presentation. 2. Patients giving valid consent. 3. Patients in active stage of induced labour with cervical dilatation of 3 to 5cms.

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. ASA grade more than II. 3. Gestational age less than 37 weeks or with malpresentation/ multiple gestation. 4. Patients with PIH /Eclampsia. 5. Pateints who have received IV/IM opiods within 4hrs of epidural insertion. 6. Entered in second stage of labour. 7. Delivery within 30mins of intrathecal analgesia. 8. Patients with contraindication to regional analgesia

Design outcomes

Primary

MeasureTime frame
To assess the total epidural dose requirement for labour analgesia in patients given intrathecal fentanyl with and without levobupivacaine for labour analgesiaTimepoint: After delivery of the baby and end of second stage of labour

Secondary

MeasureTime frame
1. Time taken to achieve VAS 0. 2. Total duration of analgesia post intrathecal injection. 3. Level of sensory blockage. 4. Incidence of motor blockage. 5. Perception of uterine contractions. 6. Haemodynamic parameters 7. Duration of labour and neonatal outcome. 8. Side effects: nausea and vomiting pruritis incidence of fetal bradycardia urinary retentionTimepoint: At the begining of labour and during labour and at the end of labour.

Countries

India

Contacts

Public ContactDr Manisha Magoo

Dr. Lakhumal Hirananad Hiranandani Hospital

meenoti@gmail.com9920627839

Outcome results

None listed

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