The effect of pneumoperitoneum-induced hypertension during laparoscopic cholecystectomy under general anesthesia on postoperative pain compared with normal blood pressure induced by intravenous nitroglycerin
Comparison of pain after laparoscopic cholecystectomy between hypertension during surgery due to pneumoperitoneum and normal intraoperative hypertension induced by intravenous nitroglycerin
Design
Two arms parallel-group randomized clinical trial with blinded postoperative care and outcome assessment. In this study, we use the block randomization method
Settings and conduct
ASA1(American Society of Anesthesiology) patients who are scheduled for laparoscopic cholecystectomy refer to Firoozgar hospital are randomly assigned to higher blood pressure ( group A : MAP (Mean Arterial Pressure) increases up to 20% higher than baseline MAP) and lower blood pressure ( group B : MAP reduces to 20% lower than baseline MAP)
The pain intensity in hours 2, 8, 12 and 24 after surgery and also the total dose of analgesics used to manage postoperative pain are recorded and compare between two groups.
In this study, the clinical caregiver and statistical analyst are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criterias: Patients aged 20 to 60 yrs without underlying disorders ( ASA1) who are scheduled for laparoscopic cholecystectomy.
Exclusion criterias: patients using any analgesic drugs during recent week.
Intervention groups
Intervention group :The intervention of this study is pneumoperitoneum-induced hypertension in cholecystectomy surgery, which causes postoperative pain.
Control group :Normal blood pressure induced by intravenous nitroglycerin injection and control or reduction of postoperative pain
Main outcome variables
Blood pressure and Heart rate during surgery
Pain score after surgery
Meperidine dosage after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210607051501N1
Registration date:2021-10-24, 1400/08/02
Registration timing:retrospective
Last update:2021-10-24, 1400/08/02
Update count:0
Registration date
2021-10-24, 1400/08/02
Registrant information
Name
Ali Khatibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8856 7458
Email address
khatibi.al@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pneumoperitoneum-induced hypertension during laparoscopic cholecystectomy under general anesthesia on postoperative pain compared with normal blood pressure induced by intravenous nitroglycerin
Public title
The effect of hypertension due to cholecystectomy surgery on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No underlying disorders (ASA 1)
Aged between 20 to 60 yr
Exclusion criteria:
Having analgesic agent during last week
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
85
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.
To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks.
For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit.
Here, based on the block 4, we divide patients into groups.
1. TTCC 2. TCTC 3. TCCT
4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
The postoperative pain intensity (VAS) will record in hours 2, 8, 12 and 24 after surgery.
Method of measurement
Visual Analogue Scale
2
Description
Pethedine dosage after surgery
Timepoint
The total dose of pethedine used for pain control will record in hours 2, 8, 12 and 24 after surgery
Method of measurement
Data record forms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group includes patients who meet the inclusion criteria and undergo laparoscopic cholecystectomy. The intervention is surgery-induced pneumoperitoneum, which increases intraoperative blood pressure and postoperative pain. To clarify the hypothesis, the patient's blood pressure is measured at different times during the operation and its effect on postoperative pain is recorded at different times. The induced gas pressure is in the range of 14 to 16 cm of water.
Category
Treatment - Other
2
Description
Control group: In the control group, patients who meet the inclusion criteria and undergo laparoscopic cholecystectomy are included .In these patients, by injecting nitroglycerin (Manufactured by Caspiantamin Pharmaceutical Company) at a dose of 5 to 10 micrograms per minute with micro Burette Infusion Set until the patient reaches normal blood pressure and records it at different times during the operation, the amount of postoperative pain is recorded at different times.