Effect of Intraoperative Intravenous lidocaine infusion And comparison with the effect of intravenous remifentanil infusion , on postoperative pain after laparoscopic cholecystectomy surgery
Effect of Intraoperative Intravenous lidocaine infusion And comparison with the effect of intravenous remifentanil infusion , on postoperative pain after laparoscopic cholecystectomy surgery
Design
Double Blinded Randomized Clinical Trial
Settings and conduct
In this study, that performed in the operating room of Shahid Faghihi Hospital in Shiraz, 81 patients undergoing laparoscopic cholecystectomy were divided into three groups.Patients in group(A) received 2% lidocaine (1.5 mg / kg) immediately after endotracheal intubation.Then the 2% lidocaine infusion at 2 mg / kg will start for 15 to 20 minutes before the skin closes.
Patients in intervention group 2(B) received Remifentanil infusion 0.5 µg / kg / min and continued until 15-20 minutes before the skin closure and patients .
In intervention group 3(C) patients received normal Saline infusion 0.9% for 20 to 15 minutes before skin closure.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:ASA I-Iاو Age 18 to 75 yearsو Patients Candidate for Laparoscopic Cholecystectomy
Exclusion Criteria: A history of allergies to topical anesthetics and lidocaine and opioids, Chronic use of opioids and nonsteroidal anti-inflammatory drug and alcohol, Pregnancy, History of (heart, liver and kidney) failure , Heart rate less than 50 minutes per minute, any block on the ECG
Intervention groups
Patients in group(A) received 2% lidocaine (1.5 mg / kg) immediately after endotracheal intubation.Then the 2% lidocaine infusion at 2 mg / kg will start for 15 to 20 minutes before the skin closes.
Patients in intervention group 2(B) received Remifentanil infusion 0.5 µg / kg / min and continued until 15-20 minutes before the skin closure and patients .
In intervention group 3(C) patients received normal Saline infusion 0.9% for 20 to 15 minutes before skin closure.
Main outcome variables
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N89
Registration date:2019-10-18, 1398/07/26
Registration timing:prospective
Last update:2019-10-18, 1398/07/26
Update count:0
Registration date
2019-10-18, 1398/07/26
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-06, 1398/08/15
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intraoperative Intravenous lidocaine infusion And comparison with the effect of intravenous remifentanil infusion , on postoperative pain after laparoscopic cholecystectomy surgery
Public title
Effect of Intraoperative Intravenous lidocaine infusion And comparison with the effect of intravenous remifentanil infusion , on postoperative pain after laparoscopic cholecystectomy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I-II
Age 18 to 75 years
Patients Candidate for Laparoscopic Cholecystectomy
Exclusion criteria:
Non-cooperation patients after surgery
Severe physical and mental disorders
Severe bradycardia (heart rate less than 40 times per minute)
Severe bleeding leading to laparotomy
A history of allergies to topical anesthetics and lidocaine and opioids
Chronic use of opioids and nonsteroidal anti-inflammatory drug and alcohol
Pregnancy
History of heart, liver and kidney failure
The heart rate is less than 50 minutes per minute and any block on the ECG
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into lidocaine (A), remifentanil (B) or normal saline (C) injection groups using computer-assigned codes which is derived from Randomization.org.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are divided into lidocaine (A), remifentanil (B) or normal saline (C) injection groups using computer-assigned codes.
Then an anesthetist unaware of study groups adminestered the drugs according to computer-selected codes syringes (containing lidocaine A) for patients with code (A) and syringe (containing normal saline C) for patients with code (C) and syringe B contains remifentanil for patients with code (B). A nurse who is blinded to the study collects information. Bolus medications are given in a 5-cc syringe and infusions in a 50-cc syringe are given by the anesthetic nurse.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2019-04-16, 1398/01/27
Ethics committee reference number
SUMS.MED.REC.1398.46
Health conditions studied
1
Description of health condition studied
Acute cholecystitis
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis
Primary outcomes
1
Description
Severity of pain in recovery
Timepoint
On arrival to recovery and every 15 minutes to 60 minutes in recovery
Method of measurement
NRS
2
Description
Severity of pain in the ward
Timepoint
Every one hour up to 6 hours, and then 12 and 24 hours
Method of measurement
NRS
Secondary outcomes
1
Description
Sedation Score
Timepoint
At the arrival to the recovery room
Method of measurement
four-point categorical scale
Intervention groups
1
Description
Intervention group: Immediately after endotracheal intubation, lidocaine 2% solution (1.5 mg / kg) will be administered slowly. Then lidocaine 2% infusion at 2 mg / kg dose will start with syringe pump infusion. and 15 to 20 minutes before closing the skin continues.
Category
Prevention
2
Description
Intervention group: Remifentanil infusion at a dose of 0.5 µg / kg / min is used and lasts up to 15-20 minutes before completion of skin closure.
Category
Prevention
3
Description
Control group: The infusion of 0.9% normal saline solution continues until 20-20 minutes before the skin closure.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Amir Javadi
Street address
Shahid Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
Phone
+98 71 3235 1087
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
vcrdep@sums.ac
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Javadi
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
amir7093209@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Sadat Fattahi Saravi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street