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CTRI Number  CTRI/2025/11/097158 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A comparative study of efficacy of Ropivacaine 0.25 versus Ropivacaine 0.375 with dexmedetomidine as adjuvant in ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy 
Scientific Title of Study   A comparative study of efficacy of Ropivacaine 0.25 percent versus Ropivacaine 0.375 percent with dexmedetomidine as adjuvant in ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jaswanth M D 
Designation  Junior Resident 
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Department of Anesthesia, Ground Floor, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesaraghatta Main Road, Chikkabanavara, Bangalore

Bangalore
KARNATAKA
560090
India 
Phone  8310552833  
Fax    
Email  jaswanth.w32@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Narendra Babu M C 
Designation  Professor  
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Department of Anesthesia, Ground Floor, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesaraghatta Main Road, Chikkabanavara, Bangalore

Bangalore
KARNATAKA
560090
India 
Phone  8310552833  
Fax    
Email  narendrababuchanappa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jaswanth M D 
Designation  Junior Resident 
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Department of Anesthesia, Ground Floor, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesaraghatta Main Road, Chikkabanavara, Bangalore

Bangalore
KARNATAKA
560090
India 
Phone  8310552833  
Fax    
Email  jaswanth.w32@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support by Sapthagiri institute of medical sciences and research centre, Bengaluru 560090 
PG stipend by Sapthagiri institute of medical sciences and research centre, Bengaluru 560090 
 
Primary Sponsor  
Name  Sapthagiri institute of medical sciences and research centre Department of Anaesthesia  
Address  Hesarghatta Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090 
Type of Sponsor  Private 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 
Dr Jaswanth M D  Sapthagiri Institute of medical sciences and research centre  Ground floor , Department of Anaesthesia. 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA 
8310552833

jaswanth.w32@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sapthagiri institute of medical sciences and research centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.25 percent versus 0.375 percent ropivacaine with a fixed dose of dexmedetomidine(50mcg)  comparision between inj 0.25% versus 0.375% ropivacaine with a fixed dose of dexmedetomidine(50mcg)as adjuvant in ultrasound-guided Erector spinae plane block. Block is given before induction and patient is monitored for 24hrs after the completion of procedure 
Intervention  ultrasound-guided Erector spinae plane block  ultrasound-guided Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy. Block is given before induction and patient is monitored for 24hrs after the completion of procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Age 18-65 years, both sexes
2 ASA physical status 1 and 2
3 Scheduled for elective laparoscopic cholecystectomy
4 Patients willing to give informed consent. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of 0.25% versus 0.375% ropivacaine with a fixed dose of dexmedetomidine as adjuvant in ultrasound-guided Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy  Postoperatively, VAS scores will be recorded at 1, 5min, 10min, 30min , 1hr , 2hr , 4hrs , 8hrs ,12hrs and 24 hours, and patients will be monitored for nausea, vomiting, sedation, respiratory depression, and shoulder pain 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   21/11/2025 
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="20"
Months="1"
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  

Laparoscopic abdominal surgery offers numerous advantages including improved early postoperative ambulation and reduced surgical trauma leading to faster recovery and fewer complications compared with open surgery However despite these benefits patients frequently experience significant postoperative pain especially in the early recovery period which can hinder mobilization increase opioid consumption and contribute to chronic pain development Effective postoperative analgesia is therefore essential for patient comfort accelerated rehabilitation and minimization of opioidrelated adverse effects

Multimodal analgesia strategies incorporating nonopioid medications and regional nerve blocks have become standard for managing pain after laparoscopic procedures The ultrasoundguided erector spinae plane ESP block first described by Forero et al in 2016 is an interfascial plane block that provides both visceral and somatic analgesia by diffusion of local anesthetic into the paravertebral and epidural spaces Its simplicity under ultrasound guidance and favorable safety profile have led to rapid adoption in thoracic and abdominal surgeries Ropivacainea longacting amide local anestheticis preferred in regional techniques due to its lower cardiotoxicity and improved motorsensory separation The concentration of ropivacaine influences block quality duration and sideeffect profile however direct comparisons of different concentrations in ESP blocks for laparoscopic surgery remain scarce Dexmedetomidine a highly selective  adrenergic agonist is increasingly used as an adjuvant in regional anesthesia When added to local anesthetic low dose dexmedetomidine prolongs sensory block duration enhances analgesia and reduces    opioid  requirements without significant hemodynamic instability The aim of this study is to compare the efficacy of 025 versus 0375 ropivacaine each with a fixed dose of dexmedetomidine as adjuvant in ultrasoundguided Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy

 
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