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CTRI Number  CTRI/2025/08/092501 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 31/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Lumbo-sacral erector spinae plane block for pain relief during child birth 
Scientific Title of Study   Efficacy of the ultrasound guided Lumbosacral Erector spinae plane block for labour analgesia: An exploratory single arm study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Gautam 
Designation  Junior Resident 
Affiliation  AIIMS Rishikesh 
Address  Department Of Anaesthesiology AIIMS Rishikesh, level 6 Medical college Building Veerbhadhra Road Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  7838308956  
Fax    
Email  abhigg99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen Talawar 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anaesthesiology AIIMS Rishikesh, level 6 Medical college Building Veerbhadhra Road Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  249203  
Fax    
Email  praveenrt64@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praveen Talawar 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anaesthesiology AIIMS Rishikesh, level 6 Medical college Building Veerbhadhra Road Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  249203  
Fax    
Email  praveenrt64@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh, Veerbhadhra Road, Uttarakhand-249203 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  Department of Anaesthesiology All India Institute of Medical Sciences, Rishikesh Virbhadra road Rishikesh 249203 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Gautam  All India Institute of Medical Sciences Rishikesh  Department of Anaesthesiology level 6 Medical college Building AIIMS Rishikesh Virbhadra Road rishikesh
Dehradun
UTTARANCHAL 		 7838308956

abhigg99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lumbosacral ESP block   Patient will receive Ultrasound Guided unilateral Lumbosacral Erector Spinae plane block for labour analgesia at S1, after negative aspiration, 0.125% bupivacaine(80ml) is given along with Dexamethasone 8mg. Then Epidural catheter will be placed in erector spinae plane under USG guidance so that tip lie at S2-S4 level.  
Comparator Agent  NOT APPLICABLE  1. Numerical Rating Scale(NRS, 0-10) for pain relief during labour at 30 mins and then 1h till 6 h post delivery 2. Heart rate- At 30 mins and then every 1h till 6h post delivery 3. NIBP- At 30 mins and then every 1h till 6h post delivery 4. Motor power in lower limbs( Modified Bromage Scale)-At 30 mins and then every 1h till 6h post delivery 5. Outcomes of labour- NVD, Forceps delivery,LSCS 6. APGAR score- at 1 min and 5 min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain Score (NRS)
 		 At 30 min and then every 1h till 6h post delivery
 
 
Secondary Outcome  
Outcome  TimePoints 
Heart Rate
 		 At 30 min and then every 1 h till 6 h post delivery 
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

at the time of top up (rescue analgesia) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [abhigg99@gmail.com].

  6. For how long will this data be available start date provided 28-02-2027 and end date provided 27-02-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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. 
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