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CTRI Number  CTRI/2024/12/078742 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 02/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study looked at whether Clonidine or Dexmedetomidine, when added to Ropivacaine, gives better pain relief for people having gallbladder surgery 
Scientific Title of Study   Comparison of the efficacy of Clonidine and Dexmedetomidine as adjuvants to Ropivacaine in bilateral erector spinae plane block in patients undergoing laparoscopic cholecystectomy - A randomised 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  Kondaveeti Anusha  
Designation  Senior resident  
Affiliation  Institute of liver and biliary sciences  
Address  Department of Anesthesia, ILBS hospital, D1, Sector D, Vasant Kunj

South West
DELHI
110070
India 
Phone  9491213659  
Fax    
Email  anookondaveeti999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Deepak. K. Tempe  
Designation  Head of the Department 
Affiliation  Institute of liver and biliary sciences  
Address  Depart of Anaesthesiology, ILBS hospital, D1, Sector D, Vasant Kunj

South West
DELHI
110070
India 
Phone  9718599401  
Fax    
Email  tempedeepak@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Kondaveeti Anusha  
Designation  Senior resident  
Affiliation  Institute of liver and biliary sciences  
Address  Department of Anaesthesiology , ILBS hospital, D1, Sector D, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9491213659  
Fax    
Email  anookondaveeti999@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Institute of liver and biliary sciences  
Address  D1, Sector D, vasant kunj, New Delhi, India, Pincode:110070, Country code: 91 
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 
Kondaveeti Anusha   Department of Anaesthesiology, Institute of liver and biliary sciences   D1, sector D, Vasant Kunj, New Delhi, India, 110070
South West
DELHI 
9491213659

anookondaveeti999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of liver and biliary sciences   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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector spinae plane block   Comparison between Clonidine and Dexmedetomidine  
Intervention  Erector spinae plane block   The ESP block will be performed pre-induction using a portable ultrasound device with a 6-13 MHz transducer. Patients will be positioned laterally, and sedo-analgesia will be administered. The block will be applied at the T8/T9 level using an in-plane technique. Group D will receive 20 mL of 0.25% ropivacaine with dexmedetomidine, Group C will receive ropivacaine with clonidine, Group R will receive ropivacaine alone, and Group N will receive no block. (Dose is 20ml of 0.25% ropivacaine : 50mg). This is a single shot dose of local anesthesia. Pain will be monitored for 24hrs after the surgery.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing elective unilateral laparoscopic cholecystectomy surgery
Agrees to participate in research
Age 18 - 65 years
BMI 25 - 35 kg/ m2
 
 
ExclusionCriteria 
Details  Patient refusal
Failure to comprehend visual analogue scale
Contraindications to intervention procedure (ESP block)
History of local anaesthetic allergy
Cardiovascular, respiratory, neurological or metabolic diseases, severe coagulopathy
History of chronic analgesic use
Failure of intervention procedures (ESP block)
History of alcohol and substance addiction
Known psychiatric disorders or use of psychiatric medications
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
clonidine and dexmedetomidine added as adjuvants to ropivacaine for ultrasound guided erector spinae plane block in laparoscopic cholecystectomy patients, prolong the duration of analgesia and improve patient comfort.   24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of efficacy of clonidine and dexmedetomidine as adjuvants to 0.25% ropivacaine
Total dose of fentanyl consumption in the postoperative period
Comparison of intraoperative fentanyl required to suppress pain response
Comparison of time to first rescue analgesia (use of PCA)
Reduction in opioid related side effects such as nausea, vomiting, sedation
Comparison of side effects related to adjuvants like hypotension, bradycardia and sedation
Comparison of intraoperative hemodynamics between the groups
 
24 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 4 
Date of First Enrollment (India)   10/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/01/2025 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 cholecystectomy is the gold standard for treating symptomatic gallstone disease, offering a less invasive approach that promotes early recovery and improved patient satisfaction. However, despite these benefits, postoperative pain remains significant, often leading to discomfort and limited mobility in the early recovery period. The primary sources of this pain include somatic pain from trocar insertion and visceral pain due to peritoneal stretching and diaphragmatic irritation caused by CO2 insufflation and increased intra-abdominal pressure.

       Ultrasound-guided erector spinae plane block (ESPB), a periparavertebral regional block, was initially introduced for managing thoracic neuropathic pain. It has since proven effective in reducing postoperative pain in various surgeries, including ventral hernia repair, breast surgeries, thoracotomies, and lumbar fusions. 

        ESPB involves the ultrasound-guided injection of local anesthetic deep to the erector spinae muscle, in the paraspinal interfascial plane, offering advantages over neuraxial techniques and paravertebral blocks due to its lower risk profile and superficial application.

          ESPB has shown efficacy in laparoscopic cholecystectomy, with studies exploring the role of α2 agonists like clonidine and dexmedetomidine in peripheral nerve blocks for prolonging sensory and motor blockades and analgesia. Their mechanisms include centrally mediated analgesia, direct action on peripheral nerves, attenuation of inflammatory responses, and α2 β adrenoceptor-mediated vasoconstriction. 

         However, their effects in fascial plane blocks are less studied. This study aims to compare the efficacy of clonidine and dexmedetomidine as adjuvants to ropivacaine in bilateral erector spinae plane blocks for laparoscopic cholecystectomy.


 
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