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CTRI Number  CTRI/2020/12/029857 [Registered on: 16/12/2020] Trial Registered Prospectively
Last Modified On: 15/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain relief after cesarean operation by nerve blocks  
Scientific Title of Study   Comparison of Analgesic Effect between Erector Spinae Plane Block and Transmuscular quadratus lumborum block after Elective Cesarean Section: A Prospective Randomized Double-Blind Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Jadon 
Designation  Chief Medical Superintendent 
Affiliation  Tata Motors Hospital 
Address  Department of Anaesthesia and pain relief service, OT complex, First floor,Tata Motors Hospital, Jamshedpur

Purbi Singhbhum
JHARKHAND
831004
India 
Phone  06576695676  
Fax    
Email  jadona@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Jadon 
Designation  Chief Medical Superintendent 
Affiliation  Tata Motors Hospital 
Address  Department of Anaesthesia and pain relief service,OT complex, First floor, Tata Motors Hospital, Jamshedpur

Purbi Singhbhum
JHARKHAND
831004
India 
Phone  06576695676  
Fax    
Email  jadona@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Jadon 
Designation  Chief Medical Superintendent 
Affiliation  Tata Motors Hospital 
Address  Department of Anaesthesia and pain relief service, OT complex, First floor,Tata Motors Hospital, Jamshedpur

Purbi Singhbhum
JHARKHAND
831004
India 
Phone  06576695676  
Fax    
Email  jadona@rediffmail.com  
 
Source of Monetary or Material Support  
Tata Motors Hospital 
 
Primary Sponsor  
Name  Dr Ashok Jadon 
Address  Department of Anaesthesia and Pain relief, OT complex, First floor,Tata Motors Hospital, Jamshedpur 
Type of Sponsor  Other [self] 
 
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 Ashok Jadon  Tata Motors Hospital, Jamshedpur  Department of Anaesthesia and Pain Relief Service, OT complex First floor
Purbi Singhbhum
JHARKHAND 		 06576695676

jadona@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee, Tata Motors Hospital  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  Erector Spinae Plane Block   Subject will receive ultrasound-guided bilateral Erector Spinae Plane Block with 20 ml, 0.25% bupivacaine and 4mg dexamethasone each side at thoracic-9 vertebral level through transverse in-plane approach.  
Comparator Agent  Trans-muscular quadratus lumborum block  Subject will receive ultrasound-guided bilateral Trans-muscular quadratus lumborum block with 20 ml, 0.25% bupivacaine and 4mg dexamethasone each side at 4th lumbar vertebral level through posterior in-plane approach.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Full-term pregnant patients scheduled for routine lower segment cesarean section under spinal anaesthesia. 
 
ExclusionCriteria 
Details  Refusal to participate.Patients with preeclampsia or Eclampsia. Patients having a contraindication to regional anesthesia or allergy to local anaesthetic drugs. Postpartum hemorrhage or surgical complications. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of pain relief  Request to first rescue analgesia with in 48 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Pain scores during rest and on coughing.
2. Amount of Tramadol used in 48 hours.
3. Postoperative nausea, vomiting 		 at 2, 4, 8, 12, 24, 48 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/12/2020 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
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 - Informed Consent Form

  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 (Others) -  Through E-mail on request.

  6. For how long will this data be available start date provided 28-12-2021 and end date provided 28-12-2023?
    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   Patients after Caesarean section often suffer from significant postoperative pain. The multimodal analgesia  (MMA) regimen is the current standard of care which includes oral analgesic drugs and regional blocks. Trans-muscular Quadratus lumborum block (TQLB) and erector spinae plane blocks (ESPB) are relatively new block which has been used for pain relief in caesarean patients as an adjuvant to MMA. However, comparative studies are lacking. Therefore, we wish to evaluate and compare the analgesic efficacy of TQLB and ESPB in cesarean patients. After acquiring informed consent, we will select 60 pregnant females scheduled for routine lower segment caesarean section (LSCS) under spinal anaesthesia and will randomise them in two equal groups (Group-Q, and Group-E) by the computer-generated random table. Each patient will receive standard anaesthetic care as per hospital protocol. LSCS will be done under spinal anaesthesia. After completion of surgery patients will be positioned in the left lateral decubitus position and will receive either ultrasound-guided ESPB or TQLB with due aseptic precautions and sterile technique. ESPB will be given at the T9 level and using the transverse in-plane approach and TQLB will be given at the L4 level using the posterior in-plane approach. Each patient will receive a bilateral block with 20ml 0.25% bupivacaine mixed with 4 mg dexamethasone at each side. Regular postoperative analgesia will be given with an injection diclophenec 75 mg 12 hourly. Rescue analgesia will be given by patient-controlled analgesia (PCA) pump with tramadol. The pump setting will be, a bolus of 25mg, lock-out time 10 minutes and 4 hour limit of 100mg. The pain assessment will be done at 2,4, 8,12,24,48 hours with a visual analogue score (VAS) of 0 to 10 where 0=no pain and 10=most severe pain during rest and during active coughing. Time to first rescue dose will be considered the duration of analgesia. The primary objective is to compare the duration of analgesia and secondary objectives are a comparison of VAS scores, amount of tramadol used and the complications of the block. Quantitative data will be checked for normality and accordingly t-test or man-Whitney test will be used. Chai-square test or fisher-exact test will be used for qualitative data. The significant difference in the duration of pain relief will be assessed with the log-rank test and Kaplan-Meier graph will be drawn. The statistical analysis will be done with the help of statistical software SPSS version 21. 
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