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CTRI Number  CTRI/2024/05/067462 [Registered on: 16/05/2024] Trial Registered Prospectively
Last Modified On: 03/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness Of Two Pain Relieving Drugs In Relieving Pain After Surgery For Removing The Gall Bladder 
Scientific Title of Study   Comparison Of Analgesic Efficacy Of Intra-Operative Intravenous Nefopam Paracetamol Combination Versus Intravenous Tramadol Paracetamol Combination On Post Operative Analgesia Among Patients Posted For Laparoscopic Cholecystectomy Under General Anaesthesia “– Randomised Double Blinded Study  
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 Basavaraj Padara 
Designation  Associate professor , Department of Anesthesia 
Affiliation  Department of Anaesthesia , S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102 
Address  S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102
S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102
Bagalkot
KARNATAKA
587102
India 
Phone  8762363790  
Fax    
Email  drbasupadara@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Basavaraj Padara 
Designation  Associate professor , Department of Anesthesia 
Affiliation  Department of Anaesthesia , S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102 
Address  S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102
S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102
Bagalkot
KARNATAKA
587102
India 
Phone  08762363790  
Fax    
Email  drbasupadara@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Basavaraj Padara 
Designation  Associate professor , Department of Anesthesia 
Affiliation  Department of Anaesthesia, S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102 
Address  S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102
S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102
Bagalkot
KARNATAKA
587102
India 
Phone  08762363790  
Fax    
Email  drbasupadara@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, S Nijalingappa Medical College and HSK hospital, Bagalkot 587102 
 
Primary Sponsor  
Name  Department of Anaesthesia  
Address  S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102 S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102 
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 Basavaraj Padara Associate professor   Department of Anaesthesia , Major OT complex , OT no 2 ,   S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102 S.Nijalingappa Medical College and HSK hospital , Bagalkot 587102
Bagalkot
KARNATAKA 		 8762363790

drbasupadara@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC-INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  laparoscopic cholecystectomy patients  Patients will be randomnly devided into 2 groups using Computer generated randomised tables. standard monitoring will be done using pulse oximeter , ECG and NIBP. standard anesthetic agents used for induction of anesthesia .15 Minutes before the extubation Group A patients will be given Inj Nefopam 20mg + inj paracetamol 15mg/kg in 100 ml ns and Group B patients will be given Inj tramadol 1.5mg/kg + inj paracetamol 15mg/kg in 100 ml ns over 15 minutes . Patients will be observed for pain using VAS scores at 0 ,5, 15, 30 minutes , 1st , 2nd , 6th , 12th and 24th hour . If the VAS score equals or is more than 4 , rescue analgesics will be given which is Inj diclo 75mg  
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Aged 18-60yrs
2.American society of Anaesthesiologist (ASA ) physical status grade 1,2
3.Posted for elective and emergency laparoscopic cholecystectomy under General Anaesthesia(GA).
 
 
ExclusionCriteria 
Details  1.Refusal to Enrol for the study
2.known allergy to study drug ,
3.K/c/o epilepsy , psychiatry disorders , opioid dependence and
4.Patients on current use of analgesics
5.Laparoscopic surgery later converted into open technique
 
 
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 
Reduction in VAS scores Expected to be better with Inj Nefopam Paracetamol combination than Tramadol paracetamol combination
 		 Assessment of Post-operative Pain using VAS scores at 0th min , 5mins , 15mins , 30mins , 1st hour , 2nd hour , 6th hour ,12 hours and 24th hour  
 
Secondary Outcome  
Outcome  TimePoints 
To Compare The Consumption Of Rescue Analgesics In The First 24 Hours Of Post-Operative Period .  First 24 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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
Modification(s)  		 Phase 3/ Phase 4 
Date of First Enrollment (India)   25/05/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Though Laparoscopic Cholecystectomy is a minimally invasive procedure ,the incidence of Significant post operative pain is estimated to be 50-70% . Control of post operative pain still remains a challenge which otherwise causes morbidity in the form of impaired pulmonary function, stress, nausea , vomiting , increased cardiac demand , prolonged hospital stay , delayed mobility etc. many drugs from different groups including opioids have been tried to alleviate this pain but significant side effects of opioids limit the liberal usage of the same and any single group of drug has not been proven to be effective in complete pain relief. The International Association for the Study of Pain (IASP)[2] differentiated types of pain and noted its chemical mediators that transduce and transmit the pain through different type and sizes of nerve  fibres that had led to co-administration of combination of analgesics that have different mechanisms of action through a strategy called “multimodal”[5] or “balanced analgesia .Hence, Selecting drugs from different  groups which act through different mechanism to alleviate the post operative pain seems logical.

In this study we intend to study the efficacy of Intravenous  Paracetamol Nefopam and intravenous Paracetamol Tramadol combinations in providing the post operative analgesia in adult patients posted for laparoscopic cholecystectomy under general anaesthesia .

After clearance from Ethical committee 50 Patients will be recruited and devided into 2 groups. Patients in Group A will receive infusion of inj Nefopam 0.3mg/kg along with Paracetamol 15mg/kg in 100ml normal saline over 10-15 minutes and Group B patients will receive  Infusion of inj Tramadol 1mg/kg along with Paracetamol 15mg/kg in 100 ml normal saline over 10-15 mins , 15 minutes prior to the completion of surgery .Post–operatively  pain will be assessed using Visual Analogue Score (VAS ) at 0th min , at 5mins , 15mins , 30mins , 1st hour , 2nd hour , 6th hour ,12 hours and 24th hour . Rescue analgesics will be used if VAS score is ≥ 4.  Total consumption of Rescue Analgesic in the first 24 hours post-operative period will be noted.  
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