Comparison of the complications of Labour analgesia with Spinal or Combined Spinal-Epidural Analgesia
Design
clinical trial with Two groups of 45 in parallel, consecutive, randomised
Settings and conduct
Comparison of the complications of Labour analgesia with Spinal or Combined Spinal-Epidural Analgesia in the delivery section of Taleghani hospital in Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: There is a possibility of natural birth; There is labor pain and active delivery phase; mother's consent to reduce delivery paint. Exclusion criteria: mother's disinclination to participate; Inability to maintain immobility during procedure; Coagulation disorders and defects in homeostasis; Increased intracranial pressure for any reason; Frank infection at the needle site; Hypersensitivity to local anesthetics or other medications using in this methods; Acute lesions of the central nervous system; Maternal hemodynamic instability (hypovolemia, hypotension) ; Heart diseases that cardiac output is severely limited; fetal distress.
Intervention groups
Spinal analgesia group: during delivery 25 to 50 microgram intrathecal fentanyl injection to L4-L5 as opioid combined with 2.5 milligram bupivacaine to enhance analgesia quality and duration
Combined spinal-epidural group: during delivery intrathecal injection of 3 millimeter 1.5% lidocaine combined with 8 to 10 milligram of 5 mg/ml bupivacaine with 0.0625 saturation with 50 microgram fentanyl injection following by 25 to 50 microgram fentanyl injection to subarachnoid space combined with 2.5 milligram bupivacaine to
Main outcome variables
hypotension, nausea, vomiting, depresion of respiration, urinary incontinance, complete spinal block, drop of FHR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160103025821N4
Registration date:2018-07-17, 1397/04/26
Registration timing:retrospective
Last update:2018-07-17, 1397/04/26
Update count:0
Registration date
2018-07-17, 1397/04/26
Registrant information
Name
Hojjat Pourfathi
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1994
Email address
pourfathih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-15, 1397/03/25
Expected recruitment end date
2018-07-11, 1397/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the complications of Labour analgesia with Spinal or Combined Spinal-Epidural Analgesia
Public title
Comparison of the complications spinal analgesia with Spinal-Epidural Analgesia in natural delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
There is a possibility of natural birth
mother's consent to reduce delivery pain
Exclusion criteria:
mother's disinclination to participate
Inability to maintain immobility during procedure
Coagulation disorders and defects in homeostasis
Increased intracranial pressure for any reason
Frank infection at the needle site
Hypersensitivity to local anesthetics or other medications using in this methods
Acute lesions of the central nervous system
Maternal hemodynamic instability (hypovolemia, hypotension)
Heart diseases that cardiac output is severely limited
fetal distress
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
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 the research and technology department, Tabriz University of Medical sciences
Street address
Research department, Daneshghah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.TBZMED.REC.1397.233
Health conditions studied
1
Description of health condition studied
the complications of Labour analgesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hypotension
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
Monitoring, Sphygmomanometer tool
2
Description
Pruritus
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
History
3
Description
Headache
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
History
4
Description
Backpain
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
History
5
Description
Urinary incontinence
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
History
6
Description
Respiratory depression
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute ,after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
PHysical examination
7
Description
Complete Spinal Block
Timepoint
Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, ...
Method of measurement
PHysical examination
8
Description
Fetal heart rate
Timepoint
Before the intervention, Immediately after the intervention, Every 5 minutes until delivery, Immediately after delivery
Method of measurement
PHysical examination
Secondary outcomes
1
Description
Studied groups
Timepoint
mmediately after the intervention, after 5 minute,after10 minute,after20minute,afer40minute,after60minute,afer1.5hour,after2hour,after3hour,...
Method of measurement
check list
Intervention groups
1
Description
Intervention group: Spinal analgesia group: during delivery 25 to 50 microgram intrathecal fentanyl injection to L4-L5 as opioid combined with 2.5 milligram bupivacaine to enhance analgesia quality and duration
Category
Prevention
2
Description
Intervention group: Combined spinal-epidural group: during delivery intrathecal injection of 3 millimeter 1.5% lidocaine combined with 8 to 10 milligram of 5 mg/ml bupivacaine with 0.0625 saturation with 50 microgram fentanyl injection following by 25 to 50 microgram fentanyl injection to subarachnoid space combined with 2.5 milligram bupivacaine to
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Taleghani hospital
Full name of responsible person
Dr. Hojjat Pourfathi
Street address
Taleghani hospital, Rah ahan square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
34424882
Phone
+98 41 3442 4425
Email
pourfathih@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. abolghasem jouyban
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
3344280 0413
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.hojjat Pourfathi
Position
Assistant Professor in Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Talghani hospital, Rah ahan square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
34424882
Phone
+98 41 3441 2000
Email
pourfathih@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.hojjat pourfathi
Position
Assistant Professor in Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Talghani hospital, Rah ahan square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
34424882
Phone
+98 41 3441 2000
Email
pourfathih@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.hojjat pourfathi
Position
Assistant Professor in Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Talghani hospital, Rah ahan square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
34424882
Phone
+98 41 3441 2000
Email
pourfathih@tbzmed.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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available