To explore lidocaine infusion can be used as anesthetic adjuvant
Design
Interventional, prospective, double-blind randomized study
Settings and conduct
This study after approval by our Institutional ethical Review Committee will be carried out in POF Hospital Wah Cantt.
Participants/Inclusion and exclusion criteria
Inclusion
• ASA I and II 18-60y
Exclusion
• ASA, III, IV, V &, and VI
• Abnormal LFT/RFT
Intervention groups
Lidocaine infusion 2ml bolus dose & the continous infusiion @ 8 drops / min till closure of incision.
Main outcome variables
L-6, IL-8 Inflammatory markers
Mobilization after surgery
VAS
General information
Reason for update
Acronym
LAT
IRCT registration information
IRCT registration number:IRCT20230830059302N1
Registration date:2023-09-01, 1402/06/10
Registration timing:prospective
Last update:2023-09-01, 1402/06/10
Update count:0
Registration date
2023-09-01, 1402/06/10
Registrant information
Name
Ayesha Afzal
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 301 5218240
Email address
afzalayesha78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-10-02, 1403/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
TO STUDY THE PHARMACOKINETIC AND PHARMACODYNAMIC EFFECTS OF LIDOCAINE INFUSION ON POSTOPERATIVE ANALGESIA WITH RESPECT TO PHARMACOGENETICS
Public title
Lidocaine as anesthetic adjuvant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
• Healthy Pakistani individuals between ages 18-60 years undergoing elective abdominal cholecystectomy. •
Patients in classes I and II of the American Society of Anesthesiologists (ASA) scale.
Exclusion criteria:
• Not of Pakistani origin •
Extremes of age •
Patients in classes III, IV, V &, and VI of the ASA scale.•
Patient with deranged Liver & renal function test (LFT/RFT) •
Pre-operative morphine consumption•
Patients on medication with immunosuppressive drugs,
Non-steroidal anti-inflammatory drugs, or steroids if taking should stop them one week before surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
300
More than 1 sample in each individual
Number of samples in each individual:
4
Blood samples taken at 0, 2 4 & 6 hrs after the start of surgery
Randomization (investigator's opinion)
Randomized
Randomization description
An interventional, prospective, double-blind randomized study
The solutions container was assigned the code A & B. Only the anesthetist knows which solution has to be given to the patient. The researcher and the patient were kept blind
Blinding (investigator's opinion)
Double blinded
Blinding description
An interventional, prospective, double-blind randomized study (62)
The solutions container was assigned the code. Only the anesthetist knows which solution has to be given to the patient. The researcher and the patient were kept blind