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CTRI Number  CTRI/2024/04/066406 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Pain relief procedure]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Quality of Pain Relief in Women Undergoing Abdominal Gynaecologic Oncology Surgery 
Scientific Title of Study   Post-operative Analgesia in Women Undergoing Open Abdominal Gynaecologic Oncology Surgery with or without Ultrasound Guided Bilateral Erector Spinae Plane Block: A Randomized Controlled 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  Anjali Gera 
Designation  Senior Consultant 
Affiliation  Sir Gangaram Hospital, New Delhi 
Address  Room No 10 SSRB Block, SGRH, Rajinder Nagar, New Delhi

Central
DELHI
110060
India 
Phone  9811571080  
Fax    
Email  anjali_chawla@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Anjali Gera 
Designation  Senior Consultant 
Affiliation  Sir Gangaram Hospital, New Delhi 
Address  Room No 10 SSRB Block, SGRH, Rajinder Nagar, New Delhi

Central
DELHI
110060
India 
Phone  9811571080  
Fax    
Email  anjali_chawla@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Derish David 
Designation  DNB Trainee 
Affiliation  Sir Gangaram Hospital 
Address  Room No 10 SSRB Block, SGRH, Rajinder Nagar, New Delhi

Central
DELHI
110060
India 
Phone  7012768937  
Fax    
Email  derishdavidukken@gmail.com  
 
Source of Monetary or Material Support  
Sir Gangaram Hospital, Rajinder Nagar, New Delhi-110060  
 
Primary Sponsor  
Name  Sir Gangaram Hospital, New Delhi  
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Gangaram Hospital , Rajinder Nagar, New Delhi, 110060 
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 ANJALI GERA  OT Complex  Fifth Floor SSRB Building, Sir Ganga Ram Hospital. New Delhi
Central
DELHI 
9811571080

anjali_chawla@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee Sir Gangaram Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A (ESP)   Single shot USG guided bilateral Erector spinae plane block will be performed under strict aseptic precautions after induction of GA. 
Comparator Agent  Group B (Control)  Erector spinae plane block will not be administered in this group of patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. ASA I-III
2. Patients undergoing elective open abdominal gynaecologic oncology surgery 
 
ExclusionCriteria 
Details  1.Emergency surgery
2.Anomalies of vertebral column
3.Any lesion obscuring sonoanatomy
4.Blood or CSF tap during the procedure
5.Failed blocks
6.Patient on anticoagulants or bleeding diathesis
7.Previous history of local anaesthetic allergy
8.History of obstructive sleep apnoea
9.Patients not consenting to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Total epidural fentanyl consumption  After 24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative vitals including heart rate, blood pressure, Post-operative pain using 10cm Visual Analogue Scale (VAS) score, PONV and sedation.  30min,2hr,4hr,6hr,12hr,24hrs
 
 
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)   08/05/2024 
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 Applicable 
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 - NO
Brief Summary  
Adequate postoperative analgesia can reduce morbidity and mortality associated with open
abdominal gynaecologic oncology surgery by allowing early ambulation, decreasing hospital
stay, thromboembolism, and other adverse outcome. Routinely opioids are used for managing
post-operative pain relief after major surgery with associated side effects like respiratory
depression, nausea, vomiting, constipation and drowsiness. Opioids delivered through epidural
route offer advantage of superior pain relief with reduction in the consumption. However,
epidural analgesia is associated with adverse effects like hypotension, delayed ambulation, ileus
and failed block.
USG guided bilateral erector spinae plane block is a comparatively new analgesic modality in
thoracic and abdominal surgery which is easy to administer and proposed to have comparable
analgesia and decreased complications compared to that with epidural analgesia.
This is a randomized controlled study to be conducted among 60 adult females undergoing
elective open abdominal gynaecologic oncology surgery under general anaesthesia with patient
controlled epidural analgesia (PCEA). Patients will be randomly allocated to two groups (Group
A, Group B) of 30 each. Group A will receive ultrasound (USG) guided bilateral erector spinae
plane block. Group B will not receive erector spinae plane block. Post-operative consumption of
fentanyl via PCEA pump and rescue analgesia with systemic opioids received will be assessed
for 24 hours. Post-operative analgesia in terms of visual analogue scale (VAS), haemodynamic
changes, sedation, nausea and vomiting will be compared between both the groups. We
hypothesise that USG guided bilateral erector spinae plane block could provide adequate post-
operative analgesia thereby reducing post-operative fentanyl consumption in women undergoing
open abdominal gynaecologic oncologic surgery with lesser side effects.
 
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