Comparison of the effect of single preoperative dose of Gabapentin and Pregabalin on postoperative pain after laparoscopic cholecystectomy in patients
Design
Clinical trial with parallel control group, randomized, Control with placebo, single center trial, Sample size 75 people.
Settings and conduct
Kowsar Hospital.
Patients are divided into three groups: placebo (control group), gabapentin consumption (intervention group 1), and pregabalin consumption (intervention group 2) and enter the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 25 to 60 years; Candidates for elective laparoscopic cholecystectomy.
Exclusion criteria: Drug addiction; Liver or kidney disorders; Taking anticonvulsants or antidepressants; Breastfeeding.
Intervention groups
Intervention group 2: One hour before the operation, the patient is given 600 mg of gabapentin capsules with some water. Paracetamol ampules are used to relieve postoperative pain in patients.
Intervention group 2: One hour before the operation, the patient is given 150 mg of pregabalin capsule with some water. Paracetamol ampules are used to relieve postoperative pain in patients.
Control group: One hour before the operation, the patient is given a placebo (domperidone 10 mg capsule) with a little water. Paracetamol ampules are used to relieve postoperative pain in patients.
Main outcome variables
Pain; Frequent demand for narcotic housing; Duration of surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N67
Registration date:2021-05-24, 1400/03/03
Registration timing:prospective
Last update:2021-05-24, 1400/03/03
Update count:0
Registration date
2021-05-24, 1400/03/03
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of single preoperative dose of Gabapentin and Pregabalin on postoperative pain after laparoscopic cholecystectomy in patients
Public title
Comparison of the effect of single preoperative dose of Gabapentin and Pregabalin on postoperative pain after laparoscopic cholecystectomy in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25 to 60 years
Candidates for elective laparoscopic cholecystectomy
Exclusion criteria:
Drug addiction
Liver or kidney disorders
Taking anticonvulsants or antidepressants
Breastfeeding
Age
From 25 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated randomly with simple sequential allocation in one of the three study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
IR.SEMUMS.REC.1400.012
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
At 1, 2, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Frequent demand for narcotic housing
Timepoint
Number of times the patient requests after the operation
Method of measurement
Questionnaire
3
Description
Duration of surgery
Timepoint
From the beginning of the surgery to its end
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 2: One hour before the operation, the patient is given 600 mg of gabapentin capsules with some water. Paracetamol ampules are used to relieve postoperative pain in patients.
Category
Treatment - Drugs
2
Description
Intervention group 2: One hour before the operation, the patient is given 150 mg of pregabalin capsule with some water. Paracetamol ampules are used to relieve postoperative pain in patients.
Category
Treatment - Drugs
3
Description
Control group: One hour before the operation, the patient is given a placebo (domperidone 10 mg capsule) with a little water. Paracetamol ampules are used to relieve postoperative pain in patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Setareh Soltany
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Setareh Soltany
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Setareh Soltany
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elahe Pasand Masoumi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available