Protocol summary

Summary
In this study, we decided to introduce a method of anesthesia for cervical cerclage in parturients which does not produce any side effect on fetus and lead to rapid recovery and early discharge of patient from hospital. This study was accomplished on 30 parturients. Inclusion criteria were pregnant woman; cervical cerclage operation; age 18-40 years old and patients consent. Exclusion criteria were presence of contraindication to spinal anesthesia; allergy to local anesthetic drugs; allergy to narcotics; positive history of analgesic and sedative drugs consumption. The patients were divided randomly to two equal groups by colored cards. Initially 500ml ringer was administered to the patients. Before spinal anesthesia, blood pressure and heart rate were recorded. For spinal anesthesia, patients of one group received 10 mg bupivacaine 0.5% (2ml) and the other group received 5mg bupivacaine 0.5% (1ml) with 10µg fentanyl (0.2 ml) and 0.8 ml normal saline in sitting position. Then in supine position blood pressure and heart rate were measured 2, 4, 6, 8, 10, 15, and 20 minutes after spinal anesthesia and in the recovery room. In the presence of decreased blood pressure to less than 90 mmHg or 20% of baseline level, we administered ephedrine. The time of T10 sensory block establishment and also maximum level of sensory block was determined by pinprick method. We used Bromage score for evaluation of motor block and maximum level of motor block was recorded. At the end of operation, the onset time of ability to movement was recorded. Headache, nausea, vomiting and itching were recorded if they occurred.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405157695N5
Registration date: 2014-07-16, 1393/04/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-16, 1393/04/25
Registrant information
Name
Seyedeh Masoumeh Hosseini Valami
Name of organization / entity
Qazvin University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1334 8419
Email address
smhosseiniv@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for research of Qazvin University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of spinal anesthesia with bupivacaine versus bupivacaine and fentanyl on sensory and motor block in cervical cerclage operation
Public title
Comparison the effects of spinal anesthesia with bupivacaine versus bupivacaine and fentanyl on sensory and motor block in cervical cerclage operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant woman; cervical cerclage operation; age 18-40 years old; patients consent Exclusion criteria: presence of contraindication to spinal anesthesia; allergy to local anesthetic drugs; allergy to narcotics; positive history of analgesic drugs consumption; positive history of narcotic and sedative drugs consumption
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2012-07-23, 1391/05/02
Ethics committee reference number
28/20/6180

Health conditions studied

1

Description of health condition studied
Cervical incompetency
ICD-10 code
N88.3
ICD-10 code description
Investigation and management of (suspected) cervical incompetence in a nonpregnant woman

Primary outcomes

1

Description
Level of sensory block
Timepoint
Every 2 min
Method of measurement
Pinprick

2

Description
Motor block
Timepoint
Every 2 min
Method of measurement
Bromage score

Secondary outcomes

1

Description
Headache
Timepoint
Continous monitoring
Method of measurement
By questioneer

2

Description
Nausea and vomiting
Timepoint
Continous monitoring
Method of measurement
Visual

3

Description
Itching
Timepoint
Continous monitoring
Method of measurement
Visual

Intervention groups

1

Description
In patients of the first group, 10mg bupivacaine 0.5% (2ml) was injected in subarachnoid space.
Category
Prevention

2

Description
In patients of the second group, 5mg bupivacaine 0.5% (1ml) with 10µg fentanyl (0.2 ml) and 0.8 ml normal saline were injected in subarachnoid space.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Seyedeh Masoumeh Hosseini Valami M.D.
Street address
Talaghani Blvd, Kosa Alley
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Sayed Assefzadeh
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd
City
Qazvin
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 of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Masoumeh Hosseini Valami, M.D.
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
smhosseiniv@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Abbas Hosseini Jahromi, M.D.
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
sahosseinij@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Abbas Hosseini Jahromi, M.D.
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
sahosseinij@qums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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