Comparing postoperative pain in Laparoscopic cholecystectomy under spinal anesthesia with general anesthesia in symptomatic cholelithiasis: A randomized clinical trial
we compare postoperative pain in laparoscopic cholecystectomy under spinal anesthesia (SA) with general anesthesia in symptomatic cholelithiasis patients to show spinal anesthesia is a better technic considering pain.
Design
randomized clinical trial on 32 patients with a control group, parallel and non-blinded.
Settings and conduct
study was conducted in Aria and Farabi hospitals in Mashhad. both methods of anesthesia was done according to guidelines.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients diagnosed with symptomatic cholelithiasis, patients with American Society of Anesthesiologists physical status I, II, and III.
Exclusion criteria: having a history of severe nausea and vomiting, using antiemetic and analgesic medication in the last 24 hours, having allergic response to anesthetics and coagulopathy disorders.
Intervention groups
In the intervention group, patients received spinal anesthesia, and the control group was general anesthesia.
Main outcome variables
Postoperative pain; mean arterial pressure; heart rate; nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200718048125N1
Registration date:2020-12-26, 1399/10/06
Registration timing:retrospective
Last update:2020-12-26, 1399/10/06
Update count:0
Registration date
2020-12-26, 1399/10/06
Registrant information
Name
Hamed Beyzaii
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3765 5378
Email address
hmd_beyzaii@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-13, 1397/03/23
Expected recruitment end date
2019-06-13, 1398/03/23
Actual recruitment start date
2018-07-14, 1397/04/23
Actual recruitment end date
2019-07-14, 1398/04/23
Trial completion date
2019-08-14, 1398/05/23
Scientific title
Comparing postoperative pain in Laparoscopic cholecystectomy under spinal anesthesia with general anesthesia in symptomatic cholelithiasis: A randomized clinical trial
Public title
Effect of spinal anesthesia on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with symptomatic cholelithiasis
Patients with body mass index of less to equal of 32 Kg/m2
Patients with American Society of Anesthesiologists (ASA) physical status I, II, and III.
Exclusion criteria:
having a history of severe nausea and vomiting in last 24 hours
using antiemetics in the last 24 hours
using analgesic medications in the last 48 hours
having an allergic response to anesthetics
having coagulopathy disorders
seen deformity of vertebral bones
addiction or drug abuse
having skin injury in the place of injection for anesthesia
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. Random numbers between 0 and 1 were generated using the calculator. Patients that received codes between 0 and 0.5 were located in general anesthesia group and patients that received codes between 0.5 and 1 were located in spinal anesthesia group.
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 Islamic Azad University, Mashhad branch
Street address
No. 8, Emam Khomeini Ave, Shahinfar Medical School
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2018-05-23, 1397/03/02
Ethics committee reference number
IR.IAU.MSHD.REC.1397.005
Health conditions studied
1
Description of health condition studied
cholelithiasis
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Postoperative pain
Timepoint
during recovery and 2, 4 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Heart rate
Timepoint
before surgery, after induction, first, second, third 15 minutes after surgery and in recovery
Method of measurement
Clinical examination
3
Description
Mean arterial pressure
Timepoint
First, second, and third 15 minutes after surgery
Method of measurement
Clinical examination
4
Description
Postoperative nausea and vomiting
Timepoint
during recovery
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Spinal anesthesia; 26-gauge spinal needle (Dr.J Tianjin Hanaco Medical Co. Tianjin, China) was introduced, then 0.5% Bupivacaine mixed with 0.2 μg of Sufentanil was injected at either the third or fourth lumbar epidural space with median or paramedian approach.
Category
Treatment - Surgery
2
Description
Control group: General anesthesia; 5 mg/kg Thiopentone Sodium, 0/5 mg/kg Atracurium Besylate, 2 mg Midazolam, 3 μg/kg Sufentanil were administered, then 100 μg/kg/min Propofol mixed with N2O were infused.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Hamed Beyzaii
Street address
No.1, Kowsar Blvd, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3881 7980
Email
hmd_beyzaii@yahoo.com
2
Recruitment center
Name of recruitment center
Aria hospital
Full name of responsible person
Hamed Beyzaii
Street address
No. 3, Pasdaran Ave, Chamran street, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3222 9094
Email
hmd_beyzaii@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeed Abtahi
Street address
Shahinfar Faculty of Medicine, Imam Khomeini Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3225 6291
Email
IMRC@mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Hamed Beyzaii
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahinfar faculty of medicine, Imam Khomeini Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3225 6291
Email
hmd_beyzaii@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamed Beyzaii
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No48. 6th baharestan st. Sadjad blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3765 5378
Fax
Email
hmd_beyzaii@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamed Beyzaii
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No48. 6th baharestan st. Sadjad blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3765 5378
Fax
Email
hmd_beyzaii@yahoo.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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available