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CTRI Number  CTRI/2026/03/105656 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 07/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A double blinded three arm study comparing administration of local anaesthetics intraperitoneally to reduce post-operative laparoscopic pain. 
Scientific Title of Study   A double blinded three arm study comparing administration of saline, levobupivacaine, levobupivacaine with dexmedetomidine intraperitoneally to reduce post-operative laparoscopic pain. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
RC/2025/72  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lijoe Reuben 
Designation  MS GENERAL SURGERY 
Affiliation  Pondicherry Institute of medical sciences 
Address  Room no: 616, OPD extension building,Pondicherry institute of medical sciences, ganapthichetikullam , Kalapet, Pondicherry.
Pondicherry Institute of medical sciences Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014.
Pondicherry
PONDICHERRY
605014
India 
Phone  6385525552  
Fax    
Email  lijoe2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Peter Manoharan 
Designation  MS GENERAL SURGERY 
Affiliation  Pondicherry Institute of medical sciences 
Address  Villa -4 ,Pondicherry institute of medical sciences, ganapthichetikullam , Kalapet, Pondicherry.
Pondicherry Institute of medical sciences Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014.
Pondicherry
PONDICHERRY
605014
India 
Phone  6385525552  
Fax    
Email  jeenu18@gmail.com  
 
Details of Contact Person
Public Query  
Name  Lijoe Reuben 
Designation  MS GENERAL SURGERY 
Affiliation  Pondicherry Institute of medical sciences 
Address  Room no: 616, OPD extension building,Pondicherry institute of medical sciences, ganapthichetikullam , Kalapet, Pondicherry.
Pondicherry Institute of medical sciences Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014.
Pondicherry
PONDICHERRY
605014
India 
Phone  6385525552  
Fax    
Email  lijoe2000@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014 
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 Lijoe Reuben  Pondicherry Institute of Medical Sciences  Surgery OPD - 230 Pondicherry Institute of Medical Sciences, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY 		 6385525552

lijoe2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS institute Ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intraperitoneal instillation of levobupivacaine in patients undergoing laparoscopic surgery.  Administration of 0.5% levobupivacaine intraperitoneally by irrigation cannula for 1 minute in patients undergoing laparoscopic surgery to reduce post operative pain. 
Comparator Agent  Intraperitoneal instillation of levobupivacaine in patients undergoing laparoscopic surgery.  Comparing if 0.5% levobupivacaine reduces post operative VAS score more than 0.9% saline and 0.5% levobupivacaine with dexmedetomidine 1mcg/kg 
Intervention  Intraperitoneal instillation of levobupivacaine with dexmedetomidine in patients undergoing laparoscopic surgery.  Administration of 0.5% levobupivacaine with 1mcg/kg dexmedetomidine intraperitoneally by irrigation cannula for 1 minute in patients undergoing laparoscopic surgery to reduce post operative pain. 
Comparator Agent  Intraperitoneal instillation of levobupivacaine with dexmedetomidine in patients undergoing laparoscopic surgery.  Comparing if 0.5% levobupivacaine reduces post operative VAS score more than 0.9% saline and 0.5% levobupivacaine. 
Intervention  Intraperitoneal instillation of saline in patients undergoing laparoscopic surgery.  Administration of 0.9% saline intraperitoneally by irrigation cannula for 1 minute in patients undergoing laparoscopic surgery to reduce post operative pain. 
Comparator Agent  Intraperitoneal instillation of saline in patients undergoing laparoscopic surgery.  Comparing if 0.9% saline reduces post operative VAS score more than 0.5% levobupivacaine and 0.5% levobupivacaine with dexmedetomidine 1mcg/kg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.ASA grade -I
2.ASA grade-II
3.Age group between 18 and 70 years undergoing laparoscopic procedure
 
 
ExclusionCriteria 
Details  •Previous history of allergies to the study drug. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the postoperative pain scores VAS among patients receiving intraperitoneal levobupivacaine, levobupivacaine with dexmedetomidine and normal saline.  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
-To measure the duration of analgesia provided by 0.9% normal saline ,0.5% levobupivacaine, 0.5% levobupivacaine with 1mcg/kg dexmedetomidine.
-To measure the total doses of analgesic (opioid) consumption in each group.
 		 24 HOURS 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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 3 
Date of First Enrollment (India)   18/03/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

To compare the postoperative pain scores VAS among patients receiving intraperitoneal levobupivacaine, levobupivacaine with dexmedetomidine and normal saline.


 
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