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CTRI Number  CTRI/2022/06/043601 [Registered on: 30/06/2022] Trial Registered Prospectively
Last Modified On: 31/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Does Dexamethasone and Lignocaine combination relieves Propofol induced pain effectively..? 
Scientific Title of Study   Efficacy of Combination Intravenous Lignocaine and Dexamethasone on Propofol Injection-site Pain: A Randomized double blinded Clinical Trial in Adult Surgical Patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pochinapeddi Seetharama Prasad 
Designation  M.D Anaesthesiology 
Affiliation  Chettinad Hospital and Research Institute  
Address  Chettinad Hospital and Research Institute kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  08978211211  
Fax    
Email  ram20mbbs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Merlin Shalini Ruth 
Designation  Professor Department of MD Anaesthesiology 
Affiliation  Chettinad Hospital and research institute  
Address  Chettinad Hospital and Research Institute kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  9790983957  
Fax    
Email  merlin5shalini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Merlin Shalini Ruth 
Designation  Professor Department of MD Anaesthesiology 
Affiliation  Chettinad hospital and research institute  
Address  Chettinad Hospital and Research Institute kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  9790983957  
Fax    
Email  merlin5shalini@gmail.com  
 
Source of Monetary or Material Support  
Clinical Therapeutics/ Volume 30, Number 6, 2008 PUBMED ORIGIN doi:10.1016/j.clinthera.2008.05.019 0149-2918  
 
Primary Sponsor  
Name  Pochinapeddi Seetharama Prasad 
Address  Chettinad Hospital and Research Institute kelambakkam 
Type of Sponsor  Other [INDIVIDUAL] 
 
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 
Pochinapeddi Seetharama Prasad  Chettinad Hospital and Research Institute  Chettinad Hospital and Research Institute kelmbakkam 1st floor ICU complex Operation theatre
Kancheepuram
TAMIL NADU 
08978211211

ram20mbbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMITTE-CARE  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 
Intervention  DEXAMETHASONE  2 ml dexamethasone plus 2ml normal saline so total volume is 4 ml is given over 10 seconds after torniquet applied over the forearm then torniquet is released after 1 minute and 25 percentage of 2 mg per kg total dose propofol is injected at a rate of 0.5 ml per second then pain is assessed by asking open ended question does it hurt every 5 seconds pain score is assessed by mccririck and hunter scale  
Intervention  DEXAMETHASONE PLUS LIGNOCAINE  2 ml dexamethasone plus 1ml normal saline plus 1ml lignocaine so total volume is 4 ml is given over 10 seconds after torniquet applied over the forearm then torniquet is released after 1 minute and 25 percentage of 2 mg per kg total dose propofol is injected at a rate of 0.5 ml per second then pain is assessed by asking open ended question does it hurt every 5 seconds pain score is assessed by mccririck and hunter scale  
Intervention  LIGNOCAINE   1ml lignocaine plus 3ml normal saline so total volume is 4 ml is given over 10 seconds then torniquet applied over the forearm then torniquet is released after 1 minute and 25 percentage of 2 mg per kg total dose propofol is injected at a rate of 0.5 ml per second then pain is assessed by asking open ended question does it hurt every 5 seconds pain score is assessed by mccririck and hunter scale  
Comparator Agent  NORMAL SALINE  4ml normal saline is given over 10 seconds after torniquet applied over the forearm then torniquet is released after 1 minute and 25 percentage of 2 mg per kg total dose propofol is injected at a rate of 0.5 ml per second then pain is assessed by asking open ended question does it hurt every 5 seconds pain score is assessed by mccririck and hunter scale Lignocaine, Dexamethasone, Lignocaine + Dexamethasone are compared with normal saline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Age group between 18 & 75 years
ASA grade 1,2 & 3
Elective & Emergency surgeries under G.A 
 
ExclusionCriteria 
Details  Patients not willing to be in the study group,
Pregnant patients
Known allergy to study drugs
Patients with neurological disorders
Received analgesic medication < 24 hours before surgery
Infection at the site of injection
thrombophlebitis
psychiatric disorders
renal, hepatic, or cardiac problems
 
 
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 
To evaluate the analgesic effect of dexamethasone,lignocaine alone or in combination in reducing the incidence of propofol injection pain.
 
it is evaluated after 1 minute of injecting the study drug , and during the beginning of injection of propofol 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the severity of propofol injection site pain with Dexamethasone, Lignocaine alone or in combination  severity of propofol injection pain will be assessed at the end of the study approximate duration for total study 3 to 4 months  
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/06/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  30/06/2022 
Date of Study Completion (Global) 27/10/2022 
Estimated Duration of Trial   Years="0"
Months="4"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Propofol is used intravenously for the induction and maintenance of anaesthesia.

 

However, pain in the injection site of the arm is one of the main disadvantages of propofol.

 

The incidence of propofol injection site pain has been reported to vary from 80% to 90% when veins on

 the dorsum of the hand is used for injection. 

 

•In different studies the authors concluded that lignocaine pre-treatment with a rubber tourniquet on the

 forearm was effective to decrease pain on injection.

 

However, the failure rate was about 15-40%. despite this lignocaine or dexamethasone did not

 completely control propofol-induced pain despite various methods to reduce propofol injection pain, the

 most effective methods not identified; thus, combination therapy suggested

 

Propofol releases kininogen from the vein wall, which triggers a local kinin cascade, The action of the

 products of the kinin cascade on the nociceptor may be enhanced by prostaglandins.

 

Dexamethasone inhibits prostaglandin synthesis and also inhibits bradykinin synthesis, a product of the

 plasma kallikrein-kinin cascade as a potent anti-inflammatory agent

 

In addition, dexamethasone added to lignocaine for regional IV anaesthesia has been reported to improve

 analgesia 

 

Thus, as further research is required the present study was conducted to evaluate the efficacy of

 

Dexamethasone, Lignocaine or combination is associated with additional analgesic efficacy compared

 with either treatment alone in Indian population

 

 
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