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CTRI Number  CTRI/2023/10/058555 [Registered on: 12/10/2023] Trial Registered Prospectively
Last Modified On: 11/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of transdermal diclofenac patch with IM diclofenac for post operative analgesia in lap chole  
Scientific Title of Study   Compare the efficacy of transdermal diclofenac patch with intramuscular diclofenac for post op analgesia in laparoscopic cholecystectomy:Randomized 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  Dr Himanshu Singh 
Designation  Junior resident 
Affiliation  Rohilkhand medical college and hospital 
Address  Department of anaesthesiology rohilkhand medical college and hospital bareilly up

Bareilly
UTTAR PRADESH
243006
India 
Phone  9720182118  
Fax    
Email  singh.himanshu9095@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Uma Rani Purohit 
Designation  Professor 
Affiliation  Rohilkhand medical college and hospital 
Address  Room no 2062 d Department of Anaesthesiology rohilkhand medical college and hospital bareilly up india

Bareilly
UTTAR PRADESH
243006
India 
Phone  9927004515  
Fax    
Email  umapurohit58@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sarfaraz Ahmad 
Designation  Associate professor 
Affiliation  Rohilkhand Medical college and Hospital 
Address  Department of anaesthesiology Rohilkhand Medical college and Hospital bareilly up

Bareilly
UTTAR PRADESH
243006
India 
Phone  7088833111  
Fax    
Email  sarfaraz_ahm2000@yahoo.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College and Hospital Bareilly 
 
Primary Sponsor  
Name  Rohilkhand medical college and hospital 
Address  Department of Anaesthesiology Bareilly up 
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 Uma Rani Purohit  Rohilkhand Medical College and Hospital  Department of Anaesthesiology
Bareilly
UTTAR PRADESH 		 9927004515

umapurohit58@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE RMCH BAREILLY UP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DICLOFENAC  GROUP A TRANSDERMAL DICLOFENAC PATCH of size 20 cm square containing 100 mg of diclofenac to be applied 2 hours before induction,pain relief checked for next 24 hours.total duration of intervention is for one year.  
Intervention  INJECTION DICLOFENAC 75 MG  GROUP B INJECTION DICLOFENAC 75 mg 30 minutes before extubation stat dose by intramuscular route.Total duration for intervention is for one year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American society of Anaesthesiologist (ASA) grade I or II.
Age group Between 18-60 yrs of either sex 
 
ExclusionCriteria 
Details  Pregnant females.
Patients with co-morbid diseases like diabetes, hypertension, TB, HIV, neurological,psychiatric or neuro-vascular disorders.
Patients with history of asthma,urticaria and hypersensitivity to any component of diclofenac patch or injection.
Patients with gastrointestinal tract related problems(gastritis, ulcers, bleeding & perforation).
Patients with skin diseases (eczema, fungal infection, inflammation, burn wound).
Patients with history of alcohol abuse, blood (porphyria, bleeding or clotting disorders) and vascular disorder.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic effect between transdermal patch of diclofenac and intramuscular diclofenac.
To document adverse effects.
To assess requirement of rescue analgesia.
To compare VAS and QoR-15 score for one year
 		 To compare the analgesic effect between transdermal patch of diclofenac and intramuscular diclofenac at 2,4,6,8,10,12,24 hours.
To document adverse effects at 2,4,6,8,10,12,24 hours.
To assess requirement of rescue analgesia at 2,4,6,8,10,12,24 hours.
To compare VAS score at 2,4,6,8,10,12,24 hours and QoR-15 score after 24 hours. Total Duration for one year
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   22/10/2023 
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="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  

To compare the efficacy of transdermal patch of diclofenac with intramuscular diclofenac for post operative analgesia in laparoscopic cholecystectomy patients.

Pain is the most usual symptom for which a patient seeks medical help.The International Association for the study of pain has described pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage”.

Commonly opioids and NSAIDs are used in peri-operative period to reduce the pain.Diclofenac sodium is a most common prescribed NSAID,which shows anti-inflammatory,analgesic and anti-pyretic activity.

Mechanism of NSAID action is to reduce peripheral pain by blocking the enzyme cyclooxygenase, which transforms arachidonic acid to prostaglandins.Prostaglandins are chief mediators of inflammatory reaction and stimulate peripheral pain receptors.Diclofenac is available in various forms like injectable agents, topical gel application, ophthalmic solution, rectal suppository and transdermal patch to cure pain.

There are less number of studies regarding control of acute post-operative pain of laparoscopic cholecystectomy using diclofenac transdermal patch and intramuscular diclofenac in this region.4Hence to gain further information,the present study is being conducted to compare efficacy of intramuscular diclofenac injection and transdermal diclofenac patch in post laparoscopic cholecystectomy pain management.

 
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