Postoperative pain is the most significant complaint of patients undergoing abdominal hysterectomy despite the use of mulimodal pain strategies. Neuroaxial anesthesia has opioid sparing effects and may provid better postoperative recovery when compaire with general anesthesia. our main objective in this study is compairing the effects of neuroaxial and general anesthesia on postoperative quality of recovery after abdominal hysterectomy. The study is prospective randomized controlled clinical trial. 100 healthy females will recruite and randomized to general anesthesia or neuroaxial anesthesia as their primary anesthesia regimen. The primary outcomes will global quality of recovery 40 questionnaries(Q.O.R 40) at 24 and 48 hours after the surgical procedure.Our data include this parameters: Hemodynamic changes, Postoperative pain score, nausea and vomiting. Our data will be analyzed using the using the Mann–Whitney U test, Fisher's exact test, and linear regression. A P value <0.05 will be considered statistically significant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309306148N3
Registration date:2013-10-23, 1392/08/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-23, 1392/08/01
Registrant information
Name
Hakimeh Alreza Amiri
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
halereza@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research Babol University Of Medical Sciences
Expected recruitment start date
2013-09-01, 1392/06/10
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Spinal Anesthesia vs. General Anesthesia on analgesia& postoperative quality of recovery after abdominal hysterectomy
Public title
compairing the effects of neuroaxial and general anesthesia on postoperative quality of recovery after abdominal hysterectomy.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: ASA physical status I and II females undergoing total abdominal hysterectomy for benign (noncancerous) disease.
Exclusion criteria: Patients with a history of coagulopathy; recent infectioncurrent; use of an opioid analgesic or corticosteroid; history of migraine headache; gross neurologic impairment; suspected difficult airway
Age
From 35 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2013-08-27, 1392/06/05
Ethics committee reference number
3012/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Post operative analgesia after total abdominal hysterectomy
ICD-10 code
Z90.710
ICD-10 code description
Acquired absence of uterus
Primary outcomes
1
Description
Analgesia
Timepoint
6, 24, 48 hour after surgery
Method of measurement
Visual analogues Scale
2
Description
Quality of recovery
Timepoint
24, 48 hour after surgery
Method of measurement
QOR-40 questionnaire
Secondary outcomes
1
Description
Heart Rate
Timepoint
Before induction, during surgery and after surgery
Method of measurement
ECG
2
Description
Blood Pressure
Timepoint
Before induction of anesthesia, during surgery and after surgery
Method of measurement
Non invasive BP Cuff
3
Description
Nausea & Vomiting
Timepoint
After Surgery
Method of measurement
Question & Observation
Intervention groups
1
Description
Intervention group: 17.5 mg 0.5% bupivacaine with fentanyl 25 microgram was injected into subarachnoid space.
Category
Treatment - Drugs
2
Description
Control group: General anesthesia was induced with 0.1 mg/kg morphine and fentanyl 1-2 micrograms/kg and propofol 2 mg/kg, and atracurium 0.5 mg/kg.
Continue of anesthesia will be with isoflurane 1-1.5MAC and N2O: O2 50%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Hakimeh Alereza Amiri
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Hakimeh Alereza Amiri
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
halereza@yahoo.com; ans_dep@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr HAkimeh Alereza Amiri
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
halereza@yahoo.com; ans_dep@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Hakimeh Alereza Amiri
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)