Effect of epidural saline washout versus receiving nothing on regression of sensory and motor block after epidural anesthesia with Marcaine 0.5% and fentanyl in gynecologic surgery: a double blinded randomized clinical trial
Objectives: To assess the effect of epidural saline washout versus receiving nothing on regression of sensory and motor block after epidural anesthesia with Marcaine 0.5% and fentanyl in gynecologic surgery
Design: a double blinded randomized clinical trial.
Setting and conduct: All eligible patients who are candidate for cystocele or rectocele and will refer to the Fatemieh Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a); candidate for cystocele or rectocele; (b) Having ASA class I or II.
Exclusion criteria: (a) having intracranial pressure; (b) having hemodynamic disorder.
Intervention: infusion of 30 ml normal saline single dose through epidural catheter after surgery.
Control: receive nothing.
Primary outcome: (a) assessing regression of sensory block every 10 min immediately after operation using cotton soaked in alcohol and pin prick until regression to 2 or 3 segments; (b) assessing regression of motor block every 10 min immediately after operation using Bromage scoring scale until regression to 1 or 2 score.
Secondary outcome: (a) assessing post operational pain immediately after surgery and 30 min, 1, 2, 6, and 12 hours later using VAS scoring scale; (b) mean arterial pressure immediately after surgery and 30 min, 1, 2, 6, and 12 hours later using manometer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404279014N34
Registration date:2014-05-03, 1393/02/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-03, 1393/02/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of epidural saline washout versus receiving nothing on regression of sensory and motor block after epidural anesthesia with Marcaine 0.5% and fentanyl in gynecologic surgery: a double blinded randomized clinical trial
Public title
Effect of epidural saline washout versus receiving nothing on regression of sensory and motor block after epidural anesthesia with Marcaine 0.5% and fentanyl in gynecologic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a); candidate for cystocele or rectocele; (b) Having ASA class I or II.
Exclusion criteria: (a) having intracranial pressure; (b) having hemodynamic disorder.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The first patient will be randomly assigned to intervention and control group using random number table. Then, other patients in order will be randomly assigned to either of the two groups.
Blinding: The patients will be unaware of the intervention during surgery. In addition, the physician, who conduct the intervention is different from the physician who will examine the patients and the examiner will not be aware of the intervention. Therefore, the trial will be run as double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-03-10, 1392/12/19
Ethics committee reference number
D/P/16/35/9/110
Health conditions studied
1
Description of health condition studied
Cystocele
ICD-10 code
N81.1
ICD-10 code description
Cystocele
2
Description of health condition studied
Rectocele
ICD-10 code
N81.6
ICD-10 code description
Rectocele
Primary outcomes
1
Description
assessing regression of sensory block
Timepoint
every 10 min immediately after operation until regression to 2 or 3 segments
Method of measurement
using cotton soaked in alcohol and pin prick
2
Description
assessing regression of motor block
Timepoint
every 10 min immediately after operation until regression to 1 or 2 score
Method of measurement
using Bromage scoring scale
Secondary outcomes
1
Description
assessing post operational pain
Timepoint
immediately after surgery and 30 min, 1, 2, 6, and 12 hours later
Method of measurement
using VAS scoring scale
2
Description
mean arterial pressure
Timepoint
immediately after surgery and 30 min, 1, 2, 6, and 12 hours later
Method of measurement
using manometer
Intervention groups
1
Description
infusion of 30 ml normal saline single dose through epidural catheter after surgery
Category
Treatment - Drugs
2
Description
receive nothing
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Yaser Amirabadi
Street address
Fatemieh Hospital, Pasdaran Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Beasat Hospital
Full name of responsible person
Dr Yaser Amirabadi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Beasat Hospital, Shahed Square, Behesh Ave.
City
Hamadan
Postal code
Phone
+98 81 1264 0040
Fax
Email
dr.amirabadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Beasat Hospital
Full name of responsible person
Dr Ahmad Moradi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Beasat Hospital, Shahed Square, Behesh Ave.
City
Hamadan
Postal code
Phone
+98 81 1264 0040
Fax
Email
dr.moradi_46@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)