Comparison of Intraperitoneal Ropivacaine alone and Intraperitoneal Ropivacaine with Dexmedetomidin and Fentanyl on pain management in abdominal laparoscopic
Design
This study is clinical trial and double blind.138 patients candidate elective abdominal laparoscopy in Valiasr hospital will inter this study.We will divide patients in 3 groups by simple randomization.Groups are parallel.
Settings and conduct
138 patients candidate elective abdominal laparoscopy in Valiasr hospital. This study is double blind. Outcome assessor and analyzer do not aware from grouping.Codes of group are available to analyzer and outcome assessor. We record blood pressure, heart rate, oxygen saturation, pain and amount of opioids consumed during surgery in each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients candidate laparoscopic abdominal surgery,18 to 65 years old, lack of susceptibility to used drugs, absence of cardiovascular disease and endocrine and renal disease, no smoking and no addiction, no pregnancy, body mass index more than 35
Exclusion criteria: not wanting to continue the study, refusal of the patient to inject intraperitoneally, patient that requires the insertion of a drain inside the abdomen for any reason
Intervention groups
First group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) use that total volume of it is adjusted to 50 milliliter with normal saline (Daropakhsh.Co).
Second group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) plus 1 micro gram per kilogram Dexmedetomidine (Exir Co.Iran).
Third group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) plus 1 micro gram per kilogram Fentanyl (Aboreyhan Co.Iran).
Main outcome variables
Blood pressure; heart rate; oxygen saturation; pain; amount of opioids consumed during surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N117
Registration date:2019-07-13, 1398/04/22
Registration timing:registered_while_recruiting
Last update:2019-07-13, 1398/04/22
Update count:0
Registration date
2019-07-13, 1398/04/22
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Intraperitoneal Ropivacaine alone and with Dexmedetomidin and Fentanyl on pain management in abdominal laparoscopic
Public title
Comparison Intraperitoneal Ropivacaine alone and with Dexmedetomidin and Fentanyl on pain management in abdominal laparoscopic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate laparoscopic abdominal surgery
18 to 65 years old
No susceptibility to used drugs
Absence of cardiovascular disease and endocrine and renal disease
No smoking and no addiction
No pregnancy
Body mass index more than 35
Exclusion criteria:
No willingness to continue the study
Refusal of the patient to inject intraperitoneally
Patient that requires the insertion of a drain inside the abdomen for any reason
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
138
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in three groups A and B and C.
In this method, we wrote on some cards intervention group1 and the same number of cards for intervention group 2 and the same number of cards for the control group, then the cards were mixed in a container. One card was taken out and its allocation was registered and the card was returned to the container. Then the cards were mixed again and another card was taken. This process continued to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. ِDefinition of groups A and B and C are available to analyzer and outcome assessor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Every 30 minutes during surgery and recovery and 2 hours after surgery
Method of measurement
Barometer
2
Description
Heart rate
Timepoint
Every 30 minutes during surgery and recovery and 2 hours after surgery
Method of measurement
Count
3
Description
Percent of oxygen saturation
Timepoint
Every 30 minutes during surgery and recovery and 2 hours after surgery
Method of measurement
Pulse oximetry
4
Description
Pain
Timepoint
At recovery and 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale Questionnaire
5
Description
Amount of opioids consumed during surgery
Timepoint
End of surgery
Method of measurement
Milligram
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) use that total volume of it is adjusted to 50 milliliter with normal saline (Daropakhsh.Co).
Category
Treatment - Drugs
2
Description
Intervention group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) plus 1 micro gram per kilogram Dexmedetomidine (Exir Co.Iran).
Category
Treatment - Drugs
3
Description
Intervention group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) plus 1 micro gram in kilogram Fentanyl (Aboreyhan Co.Iran).