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CTRI Number  CTRI/2022/09/045730 [Registered on: 21/09/2022] Trial Registered Prospectively
Last Modified On: 20/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ERECTOR SPINAE PLANE BLOCK FOR POST OPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY” 
Scientific Title of Study   COMPARISON OF ROPIVACAINE WITH OR WITHOUT DEXMEDETOMIDINE IN ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK FOR POST OPERATIVE ANALGESIA AND ITS EFFECT ON RESPIRATOR FUNCTION IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY. 
Trial Acronym  ESPB IN LC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VAISHALI PANDEY 
Designation  POST GRADUATION STUDENT  
Affiliation  Dr S N MEDICAL COLLEGE  
Address  Dr SN MEDICAL COLLEGE, JODHPUR
Dr S N MEDICAL COLLEGE, JODHPUR
Jodhpur
RAJASTHAN
342003
India 
Phone  8830146319  
Fax    
Email  vaishalipandey16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr ML TAK 
Designation  SENIOR PROFESSOR  
Affiliation  Dr SN MEDICAL COLLEGE  
Address  Dr S N MEDICAL COLLEGE, JODHPUR
Dr SN MEDICAL COLLEGE, JODHPUR
Jodhpur
RAJASTHAN
342003
India 
Phone  9799622552  
Fax    
Email  takml88@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr ML TAK 
Designation  SENIOR PROFESSOR  
Affiliation  Dr SN MEDICAL COLLEGE  
Address  Dr S N MEDICAL COLLEGE, JODHPUR
Dr SN MEDICAL COLLEGE, JODHPUR

RAJASTHAN
342003
India 
Phone  9799622552  
Fax    
Email  takml88@gmail.com  
 
Source of Monetary or Material Support  
Dr SN Medical College, Jodhpur  
 
Primary Sponsor  
Name  Dr S N MEDICAL COLLEGE  
Address  Dr SN MEDICAL COLLEGE, JODHPUR 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vaishali Pandey  Mahatma Gandhi Hospital   Mahatma Gandhi Hospital, Jodhpur
Jodhpur
RAJASTHAN 		 8830146319

vaishalipandey16@gmail.com 
Vaishali Pandey  Mathura Das Mathur Hospital  Mathura Das Mathur Hospital, Jodhpur
Jodhpur
RAJASTHAN 		 8830146319

vaishalipandey16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Dr Sampurnanand Medical College, Jodhpur   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 
Comparator Agent  Ropivacaine   Group R(ropivacaine group)Patients will receive 39.5ml of 0.25% Ropivacaine + 0.5ml normal saline. 
Comparator Agent  Ropivacaine & Dexmedetomidine   Group RD (ropivacaine+dexmetedomidine group)Patients will receive 39.5ml of 0.25% Ropivacaine + 0.5ml dexmedetomidine (50mics). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The patients of age 18-65 yrs of either gender of ASA category I and II undergoing laparoscopic cholecystectomy surgery under general anaesthesia who are hemodynamically stable and declared fit in pre anaesthetic check-up. 
 
ExclusionCriteria 
Details  Patients of -ASA category III & IV, with significant neurological , psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease or having any anatomical abnormality, with history of any other biliary tract surgery, having any infections or pre existing wound at the site of injection, already a diagnosed case of chronic pain syndrome or on any prolonged opioid therapy, having any coagulopathy. Patient’s refusal, or any history of lower abdominal surgery (adhesions). Patients’ with history of any known or present psychiatric illness as the pain score cannot be assessed properly and with known neurological deficits. Patients with history of allergy to the given medication. Patients who are intubated and on mechanical ventilation, or with severe traumatic brain/spinal cord injury or in shock. Surgeries who started as laparoscopic and then converted to open surgeries intra operatively or surgical time limit of laparoscopy exceeded 90minutes will be exempted from study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare quality of analgesia by Numerical Rating Scale (NRS) pain score and total opioid consumption during first 24 hours after LC.  To compare quality of analgesia by Numerical Rating Scale (NRS) pain score and total opioid consumption during first 24 hours after LC. 
 
Secondary Outcome  
Outcome  TimePoints 
The following parameters will be compared between two groups:
a) Duration of analgesia (time for request of first rescue analgesia after surgery). b)Inspiratory Capacity (IC) preoperative and postoperative patients.
c) Patient satisfaction score of both the techniques by Likerts scale.
d) Cumulative dose of rescue analgesia in 24 hours.
e) Sedation in both the groups (Ramsay Sedation Score).
e) Post operative nausea vomiting(PONV) and requirement of additional antiemetics.
f) Hemodynamic parameters(Heart rate, Mean arterial Blood pressure, Oxygen saturation, Respiratory rate).
g) Any complications/ side effect of block and drug. 		 24hours  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   22/09/2022 
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   Not yet published. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The aim of our study is to compare the effect of dexmedetomidine as an adjuvant to local anaesthetic (Ropivacaine) combined with ESPB in postoperative pain relief in patients undergoing laparoscopic cholecystectomy. 
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