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CTRI Number  CTRI/2025/11/097128 [Registered on: 10/11/2025] Trial Registered Prospectively
Last Modified On: 07/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study on pain relief and patient satisfaction after abdominal surgery using two different anesthesia techniques 
Scientific Title of Study   Analgesic Effect, Patient Satisfaction And Major Adverse Effect Following Postoperative Erector Spinae Plane Block And Local Wound Infiltration After Elective Abdominal Surgery— A Comparative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naveen Kumar Murugan 
Designation  Post Graduate Trainee 
Affiliation  R G Kar Medical College And Hospital 
Address  Deptartment of Anaesthesiology, Pain and Critical Care Medicine, 7th floor, emergency building, R G Kar Medical College And Hospital, Kolkata, West Bengal

Kolkata
WEST BENGAL
700004
India 
Phone  9500543062  
Fax    
Email  naveenvenkat0020@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Saikat Niyogi 
Designation  Professor 
Affiliation  R G Kar Medical College And Hospital 
Address  Department of Anaesthesiology, Pain and Critical Care Medicine,7th floor, emergency building, R G Kar Medical College And Hospital, Kolkata, West Bengal

Kolkata
WEST BENGAL
700004
India 
Phone  9831732443  
Fax    
Email  saikatneuro1972@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Saikat Niyogi 
Designation  Professor 
Affiliation  R G Kar Medical College And Hospital 
Address  Department of Anaesthesiology, Pain and Critical Care Medicine, 7th floor, emergency building, R G Kar Medical College And Hospital, Kolkata, West Bengal

Kolkata
WEST BENGAL
700004
India 
Phone  9831732443  
Fax    
Email  saikatneuro1972@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  R G Kar Medical College And Hospital 
Address  1, Khudiram Bose Sarani, Bidhan Sarani, Shyam Bazar, Kolkata, West Bengal 700004 
Type of Sponsor  Government 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 
Naveen Kumar Murugan  R G Kar Medical College And Hospital  Surgery Operation Theatre and Postoperative Care Unit, Khudiram Bose Sarani, Shyam Bazar
Kolkata
WEST BENGAL 
9500543062

naveenvenkat0020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, R.G.Kar Medical College  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 E  Erector Spinae Plane Block with inj.bupivacaine 0.25% 20ml after reversal  
Comparator Agent  Group L  Local Wound Infiltration with inj.Bupivacaine 0.25% 20ml after operation before extubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients posted for Exploratory Laparotomy surgery
2) ASA grade 1 and 2 patients
3) Patients with BMI less than 30 
 
ExclusionCriteria 
Details  1) Uncooperative patients
2) Cardiac and neurological diseases
3) Uncontrolled diabetes and hypertension
4) Known allergy to the drug used
5) Epilepsy
6) Any kind of preexisting neuropathy
7) Alcoholism
8) Chronic opioid use (defined as daily use of opioid for more than 3 month) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Timing of first rescue postoperative analgesia;
2) Total doses of rescue analgesic in the first postoperative 24 hrs.
3) Frequency of rescue analgesic given in the first postoperative 24hrs 
postoperative first 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1) Perioperative hemodynamic response (HR, MAP)
2) Comparison of Postoperative analgesia between two groups –[ assessed by VAS at predefined
intervals (0, 1, 2, 3, 4, 5, 6, 10, 14, 18, 22, 24 hours)]
3) patient satisfaction ( by Likert scale) at 24 hr postoperatively
4) incidence of complications. 
postoperative first 24 hours 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   05/01/2026 
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 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 - NO
Brief Summary  
This is a comparative study will be planned to initiate after obtaining approval from Institutional Ethics Committee and informed consent from all patients. 
Following a detailed pre anesthetic examination, total 72 patients of American society of Anaethesiologists(ASA) I and II, aged 18-60 years, posted for elective abdominal surgery fulfilling the inclusion criteria will be allocated for this study. They will be randomly divided into two equal groups. Group T -36  ESP block with injection bupivacaine 0.25 percent and Group R -36  LAI with injection bupivacaine 0.25 percent. Randomization will be ensured by an informatically generated random sequence run by a person who will not involved in the study. During preoperative visit, all the patients will be explained about the 100 mm visual analog scale (VAS). 
All the patients will be advised tablet diazepam (5mg) at the night before OT. In preoperative area intravenous ringer lactate solution will be started at 100ml/h and a standard anaesthetic protocol will be followed for all patients. All the standard ASA monitor like Electrocardiogram(ECG), SPO2, pulse oximetry, capnometer, blood pressure monitor and temperature monitor will be attached with patient for continuous monitoring.
Baseline values are noted before anaesthesia for all patients and will receive general anaesthesia according to a standard protocol with ASA monitoring. 
After securing IV line with an 18G cannula. Intravenous(IV) induction will be done with Inj. Fentanyl (2 mcg/kg), Inj. Loxicard (1 mg/kg), Inj. Propofol (2 mg/kg) and Inj.Atracurium (1mg/kg) will be administered for endotracheal intubation (ET). Patients will be maintained with N2O and O2 mixture in 1:1 ratio, inhalational isoflurane 0.5-1% to maintain bispectral index <50 and Inj. Atracurium (0.5 mg/kg) will be administered if TOF count more than 0.4. Intraoperative pulse rate (PR), Blood pressure (BP), oxygen saturation (SPO2) will be noted at 30 min interval till the end of operation for the surgery of duration 2 - 2½ hrs.
Intra operatively whenever there will be increase in BP and Heart Rate (HR) by more than 20% from pre-operative baseline value, will be treated with intravenously IV Fentanyl bolus 1 mcg/kg . Before reversal of neuromuscular block, the group LAI group patients will be infiltrated with 20 ml of 0.5 % bupivacaine by subcutaneous infiltration ( maximum 0.4 ml/kg) by the operating surgeon. 
On the other hand, ESPB group will receive the block in lateral position at the end of operation before reversal. Ultrasound guided linear or convex probe will be used depending on the depth of transverse process. A 22G x 80 mm needle used for ESPN block. For parasagittal view probe will be placed longitudinally beside the spine. The needle will be directed towards medial transverse process of mid level vertebra. When the needle comes to the contact with the transverse process, 20 ml 0.25% bupivacaine will be injected on either side of target vertebra. After this, all the patients will be reversed with IV Myopyrolate 5 ml (0.5 mg Glycopyrrolate and 2.5 mg neostigmine). After extubation, patient will be shifted to recovery room and when the patient will be stabilized (alderate score more than 9), all the patient transferred to Surgical ICU for immediate 24hrs after operation. 
Patient, investigator and statistician all will be remain blinded regarding the type of block. Postoperatively analgesia will be assessed with Visual analog scale (VAS) at 0, 1, 2, 3, 4, 5, 6, 10, 14, 18, 22 and 24 h. Intravenous paracetamol (15mg/ kg) 8 hourly will be administered as baseline analgesic. IV tramadol 2mg/kg will be administered if VAS score more than 4. The timing of first analgesic requirement will be considered as duration of analgesia. 
Postoperative hemodynamics (PR, BP) will also be noted at 0, 1, 2, 3, 4, 5, 6, 10, 14, 18, 22 and 24hrs. Duration of analgesia and postoperative total IV tramadol requirement will be considered as primary outcome. Patient satisfaction will be assessed by likert scale at 24 hours after surgery. Postoperative hemodynamics and any adverse effect like nausea, vomiting, sedation will be considered as secondary outcome.
 
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