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
|
|
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
|
|
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
|