Objective: To evaluated the effect of Valsalva maneuver on needle projection pain and hemodynamic responses associated with spinal puncture. Design: Randomized clinical trial. Setting: Operating room. Participants: Ninety adults, ASA physical status I and II, undergoing elective surgeries under spinal anesthesia. Interventions: A total of ninety adult patients were randomized into three equal groups. Group I (C): control; Group II (B): pressed a rubber ball (attention-diverting method); Group III (V): blew into sphygmomanometer tubing and hold the mercury column up to 30 mm Hg for a period of at least 20s. Measurements: Spinal needle projection pain was graded using numeric rating scale (NRS): 1–10, where scales of 1 –3 were rated as mild, 4–6 as moderate, and > 6 as severe. Blood pressure and heart rate were also recorded five minutes before, during and one and third minutes after spinal puncture.
General information
Acronym
--
IRCT registration information
IRCT registration number:IRCT201011285264N2
Registration date:2011-01-31, 1389/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-31, 1389/11/11
Registrant information
Name
Sussan Soltani Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2229 5296
Email address
soltanmo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2010-03-30, 1389/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the Valsalva Maneuver on Needle Projection Pain and Hemodynamic Responses During Spinal Puncture
Public title
Efficacy of the Valsalva Maneuver on Needle Projection Pain and Hemodynamic Responses During Spinal Puncture, a randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients, either sex with ASA physical status I and II, scheduled for elective surgeries under spinal anesthesia. Exclusion criteria: 1) Patients having problems in communication 2) any contraindications to spinal anesthesia 3) Patients who could not hold the mercury column up to 30 mm Hg for a period of at least 20s 4)patients whose spinal puncture could not be performed in the first attempt.
Age
From 19 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran university of medical sciences, Poorsina street, Keshavarz Avenue
City
Tehran
Postal code
1411713135
Approval date
2009-12-20, 1388/09/29
Ethics committee reference number
389
Health conditions studied
1
Description of health condition studied
spinal needle projection pain
ICD-10 code
Z41
ICD-10 code description
Procedures for purposes other than remedying health state
Primary outcomes
1
Description
pain
Timepoint
degree of pain after valsalva maneuver
Method of measurement
numeric rating scale
Secondary outcomes
1
Description
hemodynamic responses
Timepoint
5 minute before, during and 1 and 3 minute after intervention
Method of measurement
heart rate and blood pressure
Intervention groups
1
Description
Group II (B): Ball; pressed a rubber ball for diversion of patients attention (attention-diverting method)
Category
Other
2
Description
Group III (V): Valsalva; blew into sphygmomanometer tubing and hold the mercury column up to 30 mm Hg for a period of at least 20s.
Category
Other
3
Description
Group I (C): Control (no intervention)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr shariati hospital
Full name of responsible person
Sussan Soltani Mohammadi
Street address
North Kargar street, Ale-Ahmad highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Shahin Akhoondzadeh
Street address
Keshavarz avenue, Poorsina street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sussan Soltani Mohammadi
Position
assistant professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Dr Ali Shariati Hospital, North Kargar street, Ale-Ahmad highway, Tehran
City
Tehran
Postal code
1411713135
Phone
+98 21 2229 5296
Fax
+98 21 8863 3039
Email
soltanmo@sina.tums.ac.ir , soltanmo@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sussan Soltani Mohammadi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Dr Ali Shariati Hospital, North Kargar street, Ale-Ahmad highway
City
Tehran
Postal code
1411713135
Phone
+98 21 2229 5296
Fax
+98 21 8863 3039
Email
soltanmo@sina.tums.ac.ir , soltanmo@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Sussan Soltani Mohammadi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)