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Clinical Trials/CTRI/2025/08/092501
CTRI/2025/08/092501
Not yet recruiting
Not Applicable

Efficacy of the ultrasound guided Lumbosacral Erector spinae plane block for labour analgesia: An exploratory single arm study

AIIMS Rishikesh1 site in 1 country30 target enrollmentStarted: August 31, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Locations
1
Primary Endpoint
Pain Score (NRS)

Overview

Brief Summary

This is a single arm exploratory study to study efficacy of lumbosacral erector spinae plane block for labour analgesia. After taking informed written consent, patient will be shifted in OT and placed in left lateral position. Under USG guidance, lumbosacral ESP block will be given( 80 ml 0.125 percent Bupivacaine)with Dexamethasone 8mg and catheter will be placed so that tip lies at S2-S4 level. We will assess pain score as primary objective using Numerical Rating Scale at every 30 min and then every 1hour till 6 hour post delivery. We will assess Heart Rate, Non Invasive Blood Pressure at every 30 min and then every 1 hour till 6 hour post delivery. Motor blockage will be assessed using Modified Bromage score every 15 min during first hour then every 1 hour till 6 hour post delivery. .Outcome of labour will be noted and neonate APGAR score at 1 and 5 min will be seen. If NRS is more than 4, rescue analgesia( 20 ml 0.125 percent Bupivacaine) and inj. Tramadol will be given.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 1 ASA grade-I and II 2 Women in labour scheduled for normal vaginal delivery those seeking pain relief 3 Cephalic presentation 4 more than 34week gestation 5 Who are willing to give consent.

Exclusion Criteria

  • 1 ASA grade- III, IV, V 2 Participants unwilling to provide consent 3 Women with Severe pre-eclampsia with coagulopathy (INR more than 1.5, platelet count less than 75,000) 4 Cephalo-pelvic disproportion (CPD) 5 Participants with known history of drug allergy to bupivacaine or dexamethasone.

Outcomes

Primary Outcomes

Pain Score (NRS)

Time Frame: At 30 min and then every 1h till 6h post delivery

Secondary Outcomes

  • Heart Rate
  • Non invasive blood pressure(At 30 min and then every 1h till 6h post delivery)
  • Motor power in lower limb(At 30 min and then every 1h till 6h post delivery)
  • Outcome of labour
  • APGAR score(At 1 min and 5 min post delivery)
  • Sensory level(at 1 hour after the first bolus)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Abhishek Gautam

AIIMS Rishikesh

Study Sites (1)

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