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CTRI Number  CTRI/2025/03/082737 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison two drugs (Nalbuphine vs Tramadol) for post surgery pain relief  
Scientific Title of Study   Comparison Of Intravenous Nalbuphine Versus Intravenous Tramadol For Postoperative Analgesia In Patients Undergoing Elective Laparoscopic Surgeries-A Randomised Blinded 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  Dr Monisha J 
Designation  DNB RESIDENT  
Affiliation  Narayana Hrudayalaya Hospital  
Address  Dr Monisha J, DNB RESIDENT, 4th floor Anaesthesia office, Mazumder Shaw Medical center, Narayana Hrudayalaya, Narayana health City, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  7010387769  
Fax    
Email  monishajaigkm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indumathi T 
Designation  Consultant 
Affiliation  Narayana Hrudayalaya Hospital  
Address  DrIndumathi.T, Consultant, Department of Anaethesia,4th floor B block, OT & SICU complex, Mazumder Shaw Medical center

Bangalore Rural
KARNATAKA
560099
India 
Phone    
Fax    
Email  indumathi.t.dr01@narayanahealth.org  
 
Details of Contact Person
Public Query  
Name  Dr Monisha J 
Designation  DNB RESIDENT  
Affiliation  Narayana Hrudayalaya Hospital  
Address  Dr Monisha J, DNB RESIDENT, 4th floor Anaesthesia office, Mazumder Shaw Medical center, Narayana Hrudayalaya, Narayana health City, Bangalore


KARNATAKA
560099
India 
Phone  7010387769  
Fax    
Email  monishajaigkm@gmail.com  
 
Source of Monetary or Material Support  
Mazumder Shaw Medical center, Narayana Hrudayalaya Hospital, Narayana health City, Bangalore, Karnataka,India,Pin code-560099 
 
Primary Sponsor  
Name  Narayana Hrudayalaya Hospital  
Address  Narayana Hrudayalaya Hospital, Mazumder Shaw Medical center, Narayana health City,Bangalore, Karnataka,India,Pin code-560099 
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 
Dr Monisha   Narayana Hrudayalaya Hospital   Department of Anaesthesia, 4th floor,B Block,OT & SICU complex, Mazumder Shaw Medical center,Pin code-560099
Bangalore
KARNATAKA 		 7010387769

monishajaigkm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana health   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (3) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (4) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (5) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NALBUPHINE   Nalbuphine is synthetic opioid of phenanthrane series, It is partial agonist at kappa-opioid receptor(Providing Analgesia) 
Intervention  Tramadol   Tramadol is synthetic opioid,It stimulates mu receptor and decreases the reuptake of norepinephrine and serotonin 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American society of Anaethesiologist grade 1& 2 
 
ExclusionCriteria 
Details  1.Antipsychotic drugs
2.Drug allergy
3.Opioid use within last 3 months
4.Seizure disorder
5.Anticipation of difficult airway
6.Renal & Liver dysfunction
7.Substance abuse
8.Psychotic disorders 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean duration for first rescue analgesic between Nalbuphine vs Tramadol   When VAS score reaches 3/10 in the postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
Ramsay sedation score  1st 8 hours of postoperative period  
VAS score between the two groups  1st 8 hours of postoperative period  
Nausea, vomiting, respiratory depression  1st 8 hours of postoperative period 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   28/03/2025 
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="3"
Months="0"
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   We commonly use Injection.PARACETAMOL intravenously for postoperative pain management in our institution and supplement with Injection. Diclofenac or Tramadol as rescue analgesic.we are all aware of the effect of diclofenac on renal function and nausea with Tramadol, so we wanted to look into other available drugs with minimal effect on Liver and Renal function. 
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