To compare the efficacy of epidural analgesia and combined spinal epidural analgesia for painless labour in primigravida patients.

A comparative study of labour analgesia between epidural analgesia and combined spinal epidural analgesia using bupivacaine and fentanyl in primiparous parturients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/041914

Enrollment

Registered

2022-04-19

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Epidural analgesia: Using 0.125% Bupivacaine with 25mcg Fentanyl epidurally, when the patient is in first stage of labour and then repeated when the patient complains of pain till the d

Eligibility

Inclusion criteria

Inclusion criteria: 1. Only booked primigravida parturient with all antenatal investigations within normal limits. 2. ASA physical status I and II. 3. Age group between 18-35 years. 4. Height > 140 cms. 5. Patients with full term singleton pregnancy (gestational age between 37-42 weeks) in active phase of first stage of labour with good uterine contractions and cervical dilatation 3-5 cm with vertex presentation. 6. Cervical dilation >3 cm and

Exclusion criteria

Exclusion criteria: 1. ASA grade III and IV. 2. Age 35 years. 3. Preterm gestation. 4. Patients who did not give consent. 5. Patient with severe anaemia, bleeding disorders, coagulation abnormalities or on anticoagulant therapy or history of prolonged aspirin ingestion. 6. Patients with spine deformity. 7. Patients with history of spine surgery. 8. Patient with history of chronic backache. 9. Patients with pre-existing neurological or spinal disease, cardiovascular or respiratory impairment, local or systemic infection, cephalopelvic disproportion, feto placental insufficiency. 10. Fetal distress.

Design outcomes

Primary

Measure	Time frame
To compare the quality of analgesia during the labour in both the groups.Timepoint: VAS and MBS will be assessed every 15 min.	—

Secondary

Measure	Time frame
To study the side effects of the drugs and procedureTimepoint: Vital parameters (pulse rate, mean arterial pressure, respiratory rate, spo2) will be recorded at 0 (before anaestheia), 5, 15 min and then every 15 min till 1 h and then every 30 min until the delivery.	—

Countries

India

Contacts

Public ContactDr Azizul Haque

Rajendra Institute Of Medical Sciences, Ranchi

sana786cute@gmail.com7004404065

Outcome results

None listed

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