Protocol summary

Summary
Objectives: This study will perform for survey of the effect of hydrotherapy before spinal anesthesia on reduction of postdural puncture headache. Design: This study is a clinical trial on 80 patients who referred to operating room of Ghamar Hospital of Neyshabur for elective surgery under spinal anesthesia. Patients are randomly assigned to intervention or control groups. Randomization of patients is achieved using table of random numbers. Setting and conduct: After approval of the study by the Vice Chancellor for research of Neyshabur University of Medical Sciences and Ethics committee of Neyshabur University of Medical Sciences and getting informed consent, patients will enter to the study. The inclusion criteria for the study are not addiction, no history of migraine headache and use of spinal anesthesia techniques. Exclusion criteria are patient dissatisfaction and receiving different drugs or different doses on spinal anesthesia. Intervention: The patients will enter to the operating room without I.V line. Patients in intervention group will receive 500 ml Normal Saline before spinal anesthesia and patients in control group not receive normal saline before spinal anesthesia. Spinal anesthesia will perform by Bupivacaine plus Sufentanil injection using a spinal needle size of 27. Main outcome measures: Intensity of headache and backache in the patients in postoperative period will be examined by pain questionnaire in 4, 8, 24, 48 and 72 hour and 7 days after surgery on the phone. The interviewer will not know about the intervention and will be trained on evaluation of the existence of headache and backache among the patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050727773N1
Registration date: 2016-08-31, 1395/06/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-31, 1395/06/10
Registrant information
Name
Seyedeh Masoomeh Saadati
Name of organization / entity
Neyshabur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 513333964
Email address
saadatim2@nums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Neyshabur University of Medical Sciences
Expected recruitment start date
2016-08-07, 1395/05/17
Expected recruitment end date
2016-12-07, 1395/09/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of fluid therapy before Spinal Anesthesia on Reduction of Postural Puncture Headache in patients undergoing surgery.
Public title
The effect of fluid therapy on Postural Puncture Headache in patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: No addiction; No history of migraine headache; Spinal anesthesia. Exclusion criteria: Patient dissatisfaction; Receiving different drugs or different doses of drug for spinal anesthesia.
Age
From 20 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization of patients was achieved using table of random numbers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Neyshaspur University of Medical Sciences
Street address
Razi Street.Neyshapur
City
Neyshapur
Postal code
9314634814
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
IR.NUMS.REC.1394.16

Health conditions studied

1

Description of health condition studied
-
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Postdural Puncture Headache
Timepoint
1 hour after intervention; 7 hour intervention; 24 hour after intervention; 7 days after intervention;
Method of measurement
Pain questionnaire

Secondary outcomes

1

Description
backache
Timepoint
1 hour after intervention; 4 hour after intervention; 6 hour after intervention; 24 hour after intervention; 7 days after intervention
Method of measurement
Pain questionnaire

Intervention groups

1

Description
Intervention group: receive 500 ml of 0.9% normal saline 30 minute before surgery.
Category
Prevention

2

Description
Control group: do not receive fluid therapy before spinal anesthesia.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghamar Hospital
Full name of responsible person
Dr Rasgoo
Street address
Ghamar Hospital, Imam Khomeini Street, Neyshabur
City
Neyshapur

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Neyshabur University of Medical Science
Full name of responsible person
Seyedeh Masoomeh Saadati
Street address
Razi street, Neyshabur, Neyshabur university of Medical Science
City
Neyshbur
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,Neyshabur University of Medical Science
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
Neyshabur University of Medical Sciences
Full name of responsible person
Seyedeh Masoomeh Saadati
Position
Faculty member
Other areas of specialty/work
Street address
Razi street, Neyshabur University of Medical Sciences, Neyshabur,
City
Neyshpur
Postal code
93186-14139
Phone
+98 51433440
Fax
Email
saadati.msnursing@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neyshabur university of medical sciences
Full name of responsible person
Seyedeh Masoomeh Saadati
Position
Faculty member
Other areas of specialty/work
Street address
Razi Street, Neyshpur
City
Neyshapur
Postal code
Phone
+98 51433440
Fax
Email
saadati.msnursing@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Neyshabur university of medical sciences
Full name of responsible person
Seyedeh Masoomeh Saadati
Position
Faculty member
Other areas of specialty/work
Street address
Razi Street, Neyshapur
City
Neyshbur
Postal code
93186-14139
Phone
+98 935 930 0224
Fax
Email
saadati.msnursing@gmail.com
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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