The comparison of spinal anesthesia with general anesthesia on the postoperative pain after hysterectomy in patients
Design
This study recruited 40 candidates of abdominal hysterectomy with American Society of Anesthesiologists (ASA) I and II.All the patients were briefed on the pain assessment scale the day before the surgery, randomly divided into two groups of GA and SA and underwent abdominal hysterectomy using the same technique. Postoperative pain was then recorded upon admission to postanesthesia care unit (PACU)and six and twelve hours later
Settings and conduct
Patients undergoing hysterectomy in Semnan Amir Hospital. Patients will be provided with adequate explanations about each procedure and study method before inclusion. Though, they will not know on which procedure they have undergone.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
American Society of Anesthesiologists (ASA) I and II class
Candidate for hysterectomy
Exclusion Criteria
Prefer a specific method of anesthesia
Psychiatric diseases under medical treatment
Patients with chronic or acute pain
Anatomical disorder that requires a specific anesthetic method
Intervention groups
Two groups of 20 people included the general anesthesia (GA) and spinal anesthesia(SA)
Main outcome variables
Pain control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171228038117N2
Registration date:2018-02-11, 1396/11/22
Registration timing:retrospective
Last update:2018-02-11, 1396/11/22
Update count:0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Babak Hosseinzadeh zorofchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7838
Email address
babak.hoseinzadeh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
2016-12-21, 1395/10/01
Actual recruitment end date
2017-11-01, 1396/08/10
Trial completion date
empty
Scientific title
Comparing Spinal and General Anesthesia in terms of Postoperative Pain inPatients Undergoing Hysterectomy
Public title
Comparing Spinal and General Anesthesia in terms of Postoperative Pain inPatients Undergoing Hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists (ASA) I and II class
Candidate for hysterectomy
Exclusion criteria:
Prefer a specific method of anesthesia
Psychiatric diseases under medical treatment
Patients with chronic or acute pain
An anatomical disorder that requires a specific anesthetic method
Age
From 20 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were unaware of the type of anesthesia
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
Basij Ave, Semnan Town
City
Semnan
Province
Semnan
Postal code
3517816615
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
IR.SEMUMS.REC.1394.92
Health conditions studied
1
Description of health condition studied
Post Hysterectomy pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post operative pain
Timepoint
After 30 min
Method of measurement
visual analogue scale (VAS)
Secondary outcomes
1
Description
Nausea
Timepoint
0, 6 and 12 h after the operation
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Vometing
Timepoint
0, 6 and 12 h after the operation
Method of measurement
Visual Analogue Scale (VAS)
Intervention groups
1
Description
Intervention group: After anesthetic monitoring including pulse oximetry, ECG and blood pressure monitoring, premedication was administered by injecting benzodiazepine (intravenous midazolam, 2 mg) and a synthetic narcotic (intravenous fentanyl, 1 mg/kg body weight). GA was induced by injecting intravenous thiopental sodium 5 mg/kg bw, and the muscle relaxant, Atracurium, 0.5 mg/kg bw. After endotracheal intubation, inhalation anesthetic(including equal proportions of oxygen and Nitrous oxide, 4 L/min) and evaporation anesthetic (halogenated anesthetic: Isoflurane 1.2%, 1 MAC) were administered to maintainanesthesia and patients underwent mechanical ventilation using anesthesia ventilators.The patient was extubated at the end of the operation after discontinuing anesthetics and reversing the effects of the muscle relaxants using anticholineste rasessuch asneostigmine 40-70 µg/kg bw and anticholinergicssuch asintramuscular atropine 15µg/kg b w. They were then transferred to PACU (recovery room).
Category
Treatment - Drugs
2
Description
Control group: After anesthetic monitoring of the patient, including pulse oximetry, ECG and blood pressure monitoring, minimal 500 cc crytalloids serum was intravenously administered to prevent hypotension secondary to SA. After placing the patient in a seated position and using povidone-iodine solution for sterilizing the site of lumbar puncture, the L4/L5intervertebral space was identified. A cutting-tipped 25-gauge (orange) spinal needle was inserted into the intrathecal area, and the accuracy of the technique was ensured by the appearance of cerebrospinal fluid. A total of 3 cc hyperbaric bupivacaine solution 0.5%was then injected into the subarachnoid space and the patient was placed in supine position. After stabilizing SA, the position was adjusted so as to allow the local anesthetic to move toward the T8 area. A needle or alcohol-soaked cotton was used to identify the anesthetic area and the operation began after this area was stabilized. In case of agitation during operation, 1-2 mg of intravenous midazolam was administered, and the patient was transferred to PACU after the operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Hospital
Full name of responsible person
Babak Hoseinzadeh
Street address
Basij Ave, Semnan
City
Semnan
Province
Semnan
Postal code
3517816615
Phone
+98 23 3334 7834
Email
babakhz.anesthesia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Deputy Research and Technology
Street address
Basij Ave,Semnan
City
Semnan
Province
Semnan
Postal code
3517816615
Phone
+98 23 3343 7834
Email
babakhz.anesthesia@gmail.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
Babak Hoseinzadeh zorofchi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology,Kosar Hospital,Semnan University of Medical Sciences,Semnan
City
Semnan
Province
Semnan
Postal code
3517816615
Phone
+98 23 3343 7838
Fax
Email
babak.hoseinzadeh@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Babak Hoseinzadeh zorofchi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Kosar Hospital,Semnan University of Medical Sciences, Semnan
City
Semnan
Province
Semnan
Postal code
3517816615
Phone
+98 23 3343 7838
Fax
Email
babak.hoseinzadeh@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Babak Hoseinzadeh zorofchi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Kosar Hospital, Semnan University of Medical Sciences, Semnan
City
Semnan
Province
Semnan
Postal code
3517816615
Phone
+98 23 3343 7838
Fax
Email
babak.hoseinzadeh@semums.ac.ir
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