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CTRI Number  CTRI/2020/01/022656 [Registered on: 08/01/2020] Trial Registered Prospectively
Last Modified On: 01/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ERECTOR SPINAE PLANE BLOCK IN ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY 
Scientific Title of Study   EVALUATION OF POSTOPERATIVE ANALGESIA OF ERECTOR SPINAE PLANE BLOCK IN ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Garima Garg 
Designation  Resident Anaesthesiologist 
Affiliation  Employees State Insurance Cooperation Postgraduate Institute of Medical Sciences and Research  
Address  ESI Residential Complex, Basaidarapur
Ring Road
West
DELHI
110015
India 
Phone  9773842458  
Fax    
Email  garimagargaseem@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Divya 
Designation  Associate Professor 
Affiliation  Employees State Insurance Cooperation Postgraduate Institute of Medical Sciences and Research 
Address  Basaidarapur, Ring Road
Ring Road
West
DELHI
110015
India 
Phone  9891230700  
Fax    
Email  divyasth@gmail.com  
 
Details of Contact Person
Public Query  
Name  Garima Garg 
Designation  Postgraduate Student 
Affiliation  Esic PGIMSR 
Address  Department of Anaesthesia ESIC - PGIMSR, Basaidarapur Ring Road,
Department of Anaesthesia ESIC - PGIMSR, Basaidarapur Ring Road,
West
DELHI
110015
India 
Phone  9773842458  
Fax    
Email  garimagargaseem@gmail.com  
 
Source of Monetary or Material Support  
ESIPost graduate Institute of Medical Sciences and Research New Delhi 
 
Primary Sponsor  
Name  ESIPost graduate Institute of Medical Sciences and Research New Delhi 
Address  Basaidarapur, Ring Road New Delhi -11015 
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 
Garima Garg  ESI-Postgraduate Institute of Medical Sciences and Research  2nf Floor Operation theatre, Surgery OT 6 and 7, Department of Anaesthesia ESIC - PGIMSR, Basaidarapur Ring Road,
West
DELHI 		 9773842458

garimagargaseem@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC ESI PGIMSR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Undergoing lapraroscopic Cholecystectomy for gall stone disease 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector Spinae Plane Block (ESPB) wih General Anaesthesia  Patients in Test group will receive bilateral Ultrasound guided ESPB before induction of General Anaesthesia : 20 ml 0.25% levo-bupivacaine will be injected on each side 3cm lateral from midline at T7 vertebral level after negative aspiration for blood or fluid before start of surgery.  
Comparator Agent  General Anaesthesia Alone  Patients in control group will receive general anaesthesia alone General Anaesthesia technique: IV fentanyl (1-2 mcg/kg), Propofol (2–2.5 mg/kg), Vecuronium 0.1 mg/kg and ventilated manually using closed circuit with 1-2% Sevoflurane, Oxygen(50%) and nitrous oxide(50%) for 3 minutes. After adequate muscle relaxation, Laryngoscopy will be done and patient will be intubated with appropriate size cuffed endotracheal tube 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I and II.
Age 18-60 years of either sex.
Patient undergoing elective laparoscopic cholecystectomy
 
 
ExclusionCriteria 
Details  Obesity (BMI >30kgm-2)
Contraindications to regional anaesthesia
Known allergy to local anaesthetics
Bleeding diathesis
Patient on any anti-coagulant therapy
Patient on chronic analgesics
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Total postoperative analgesic consumption   24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative pain assessment: Numeric pain Rating score(NRS) at rest and movement.
Total requirement of rescue analgesia  		 30 mins, 2 hrs, 4 hrs, 6 hrs, 8 hrs, 24 hrs  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/01/2020 
Date of Study Completion (India) 29/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Sent for publication 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Aim of study is to find out the analgesic effect of Erector Spinae Plane Block (ESPB) in elective laparoscopic cholecystectomy surgeries. 

Seventy  patients  will be enrolled for this study after inclusion and exclusion criteria.  They will be allocated to one of the two groups

Written informed consent will be taken from the patients.
Group C= patients will receive general anaesthesia alone.                                                                      

Group T = patients will receive ultrasound guided-ESPB followed by general anaesthesia

After completion of the surgical procedure, and emergence from anaesthesia, the patient will be transferred to the postoperative recovery room(PACU).
Patients in both groups will receive i.v. Paracetamol 1gm 6 hourly for pain relief after surgery.
Patient will be assessed for pain by anaesthesia resident blinded to group allocation at ½, 2, 4, 6, 8 and 24hrs in recovery room.
The severity of pain at rest and movement will be assessed using   Numeric Pain Scale (NRS).
Total postoperative Analgesic consumption   - (PCA tramadol) will be recorded , Total requirement of rescue analgesic (fentanyl) for NRS >5, will be recorded.

 
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