Study comparing the pain relieving effects of erector spinae plane block (nerve block) with intravenous tramadol medication in pregnant women presenting with labour pain

Comparison of analgesic efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) with Parenteral Tramadol for Labour Analgesia: a multi-center, randomized, double blind, placebo-controlled superiority trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060359

Enrollment

340

Registered

2023-11-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: O94-O9A- Other obstetric conditions, not elsewhere classified

Interventions

Intervention1: Erector Spinae Plane Block: The procedures will be performed under aseptic precautions in the labour room complex. The patient will be positioned in the lateral decubitus or sitting pos

Eligibility

Inclusion criteria

Inclusion criteria: Primigravida women in labour scheduled for normal vaginal delivery with Singleton pregnancy, Cephalic presentation and >36 week gestation who are willing to consent

Exclusion criteria

Exclusion criteria: 1. Participants unwilling to provide consent 2. High risk pregnancy (Gestational Diabetes Mellitus [GDM], Pre-Ecclampsic toxemia [PET] 3. Cephalo-pelvic disproportion (CPD) 4. Multiparity 5. Participants with known history of drug allergy to bupivacaine or dexamethasone

Design outcomes

Primary

Measure	Time frame
Mean Numerical Rating Scale (NRS) Pain score (0-10) taken at the baseline and every hour post intervention till delivery of placentaTimepoint: Baseline 1 Hour, 2 hours, 3 hours, 4 hours, 5 hours post intervention till delivery of placenta	—

Secondary

Measure	Time frame
Patient satisfaction with pain reliefTimepoint: after delivery of the placenta;Duration of Active stage I labourTimepoint: cervical dilatation of 4 cm to 10 cm;Maternal outcomesTimepoint: from recruitment till delivery of placenta;Fetal outcomesTimepoint: 5 minutes to 1 hour after delivery	—

Countries

India

Contacts

Public ContactDr Niraj Gopinath

Sri Madhusudan Sai Institute of Medical Sciences and Research

niraj.gopinath@smsimsr.org9036119279

Outcome results

None listed

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