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CTRI Number  CTRI/2023/11/060359 [Registered on: 30/11/2023] Trial Registered Prospectively
Last Modified On: 01/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study comparing the pain relieving effects of erector spinae plane block (nerve block) with intravenous tramadol medication in pregnant women presenting with labour pain  
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niraj Gopinath 
Designation  Senior Consultant in Anaesthesia and Pain Medicine 
Affiliation  Sri Madhusudan Sai Institute of Medical Sciences and Research 
Address  Sri Madhusudan Sai Institute of Medical Sciences and Research Muddenahalli

Bangalore Rural
KARNATAKA
562101
India 
Phone  9036119279  
Fax    
Email  niraj.gopinath@smsimsr.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Niraj Gopinath 
Designation  Senior Consultant in Anaesthesia and Pain Medicine 
Affiliation  Sri Madhusudan Sai Institute of Medical Sciences and Research 
Address  Sri Madhusudan Sai Institute of Medical Sciences and Research Muddenahalli

Bangalore Rural
KARNATAKA
562101
India 
Phone  9036119279  
Fax    
Email  niraj.gopinath@smsimsr.org  
 
Details of Contact Person
Public Query  
Name  Dr Niraj Gopinath 
Designation  Senior Consultant in Anaesthesia and Pain Medicine 
Affiliation  Sri Madhusudan Sai Institute of Medical Sciences and Research 
Address  Sri Madhusudan Sai Institute of Medical Sciences and Research Muddenahalli

Bangalore Rural
KARNATAKA
562101
India 
Phone  9036119279  
Fax    
Email  niraj.gopinath@smsimsr.org  
 
Source of Monetary or Material Support  
Sri Madhusudan Sai Institute of Medical Sciences and Research Muddenahalli Chikkaballapur Karnataka 562101 
 
Primary Sponsor  
Name  Sri Madhusudan Sai Institute of Medical Sciences and Research 
Address  Muddenahalli Chikkaballapur Karnataka 562101 
Type of Sponsor  Private medical college 
 
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 Niraj Gopinath  Sri Madhusudan Sai Institute of Medical Sciences and Research  Department of Anaesthesia and Pain Medicine Room 7 First Floor Theatre complex, Muddenahalli
Bangalore Rural
KARNATAKA 		 9036119279

niraj.gopinath@smsimsr.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ramaiah Medical College Ethics Committee  Approved 
AIIMS Rishikesh Institutional Ethics Committee  Approved 
Ramaiah Medical College Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 position. Skin over the block site (Lumbar L4 spinous process) will be prepped with antiseptic solution and the skin will be anaesthetized with Lignocaine solution. Under real time ultrasound guidance, a 22-gauge, 10 cm needle is introduced into the erector spinae fascial plane. Normal saline (5-10 ml) is used to open the fascial plane (saline hydro dissection) and 35 ml of the mixture is injected into the plane. The procedure is repeated on the contralateral side. The mixture contains 2 mg/kg bupivacaine, 150 mg of lidocaine with 2 microgram/ml of adrenaline, 100 mcg clonidine and 8 mg of dexamethasone made up to 70 ml with 0.9% saline. Intralipid 20% will be available in the delivery suite at each participating hospital. One such procedure will be performed for each participant. The total time taken for the procedure is 20 minutes. 
Comparator Agent  Parenteral Tramadol  Participants randomized to the standard treatment arm will be prescribed to receive intravenous tramadol 100 mg every six-hourly up to a maximum dose of 400 mg per day. The participant will receive up to 4 interventions during the course of the labour. Each intravenous injection will take 2-3 minutes to administer.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Primigravida women in labour scheduled for normal vaginal delivery with Singleton pregnancy, Cephalic presentation and >36 week gestation who are willing to consent 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean Numerical Rating Scale (NRS) Pain score (0-10) taken at the baseline and every hour post intervention till delivery of placenta  Baseline
1 Hour, 2 hours, 3 hours, 4 hours, 5 hours post intervention till delivery of placenta 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction with pain relief  after delivery of the placenta 
Duration of Active stage I labour  cervical dilatation of 4 cm to 10 cm 
Maternal outcomes  from recruitment till delivery of placenta 
Fetal outcomes  5 minutes to 1 hour after delivery 
 
Target Sample Size   Total Sample Size="340"
Sample Size from India="340" 
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   Phase 4 
Date of First Enrollment (India)   11/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/12/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Clinical Study Report

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [niraj.gopinath@smsimsr.org].

  6. For how long will this data be available start date provided 01-08-2024 and end date provided 30-07-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Labour pain is considered to be one of the worst pains experienced. Labour analgesia should be offered to every women who demands pain relief.. However, pain relief options for Indian women are suboptimal.. In India, the practice of labour analgesia shows wide variability and in some centres, is non-existent.. Epidural analgesia (EA) is the gold standard for pain relief during childbirth.. In the developed world, 60% of women receive. In India, less than 10% of women are offered EA.. Setting up an EA service may be not feasible due to the significant cost and expertise required. Although EA provides excellent pain relief, it is not without adverse effects as well as potentially serious complications.. EA can prolong labour and increase the risk of assisted vaginal delivery.. In the rural sector, tramadol forms the mainstay, despite limited efficacy in labour. Ultrasound guided erector spinae plane block (ESPB) is a recently described technique. ESPB provides analgesia by targeting the paravertebral nerves. A few anecdotal reports suggest a role in labour analgesia .. The advantages compared to EA include technical simplicity and a favourable safety profile. The location of the ESPB away from the neural axis mitigates potentially serious complications associated with EA. ESPB is versatile and can provide widespread analgesia covering thoraco-lumbo-sacral dermatomes. Literature also suggests that the ESP block confers analgesic characteristics without motor block or haemodynamic disturbance. ESPB can be performed in coagulopathic states often seen in pregnancy. In addition, unlike EA, a single shot bilateral ESPB injection could be sufficient to provide pain relief covering the entire childbirth. These attributes make ESPB a candidate for providing cost-effective and safe and labour analgesia. We performed a service evaluation of ESPB analgesia in labour at our center. The evaluation was mandated due to poor efficacy of the standard management. In addition, there was an increase in maternal demand for caesarean section due to poorly controlled labour pain. We observed that ESPB provides adequate analgesia with high maternal satisfaction. In addition, we observed a trend of augmentation of active stage I and Stage II labour probably due to the addition of dexamethasone in ESPB. The current evidence for ESPB in Labour is limited to a few cases. We would like to formally assess the efficacy of ESPB analgesia in labour when compared to standard treatment (parenteral tramadol). 
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