Reducing Pain Intensity During Spinal Needle Insertion: Valsalva Maneuver vs. Control Technique
NCT ID: NCT04029662
Last Updated: 2020-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2019-08-01
2019-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group Valsalva Maneuver
Patients who undergo spinal anesthesia and perform Valsalva maneuver to reduce the pain intensity
Valsalva Maneuver
Performing Valsalva maneuver will reduce the pain intensity during spinal needle insertion.
Group Control
Patients who undergo spinal anesthesia and perform nothing to reduce the pain intensity
No interventions assigned to this group
Interventions
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Valsalva Maneuver
Performing Valsalva maneuver will reduce the pain intensity during spinal needle insertion.
Eligibility Criteria
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Inclusion Criteria
* Patients with no previous history of spinal anesthesia
* Patients with criteria of American Society of Anaesthesiologist (ASA) I-II
* Patients willing to participate in the study and signing informed consent form
Exclusion Criteria
* Patients with difficulty in blowing 30 mmHg for 20 seconds
* Patients having allergic reactions due to local anesthetics and opioid
18 Years
65 Years
ALL
Yes
Sponsors
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Indonesia University
OTHER
Responsible Party
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Alfan Mahdi Nugroho
Principal Investigator
Principal Investigators
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Alfan M Nugroho, MD
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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Indonesia University
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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References
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Calthorpe N. The history of spinal needles: getting to the point. Anaesthesia. 2004 Dec;59(12):1231-41. doi: 10.1111/j.1365-2044.2004.03976.x.
Agarwal A, Sinha PK, Tandon M, Dhiraaj S, Singh U. Evaluating the efficacy of the valsalva maneuver on venous cannulation pain: a prospective, randomized study. Anesth Analg. 2005 Oct;101(4):1230-1232. doi: 10.1213/01.ane.0000167270.15047.49.
Cigdem UK, Sevinc S, Esef B, Sureyya O, Muzaffer G, Akif D. [A comparison of three different needles used for spinal anesthesia in terms of squamous epithelial cell transport risk]. Rev Bras Anestesiol. 2017 Sep-Oct;67(5):468-471. doi: 10.1016/j.bjan.2017.04.011. Epub 2017 May 16. Portuguese.
Pstras L, Thomaseth K, Waniewski J, Balzani I, Bellavere F. The Valsalva manoeuvre: physiology and clinical examples. Acta Physiol (Oxf). 2016 Jun;217(2):103-19. doi: 10.1111/apha.12639. Epub 2016 Jan 5.
Macfie AG, Brimacombe J. Response to the Valsalva manoeuvre after spinal anaesthesia. Anaesthesia. 1992 Jan;47(1):13-6. doi: 10.1111/j.1365-2044.1992.tb01944.x.
Looga R. The Valsalva manoeuvre--cardiovascular effects and performance technique: a critical review. Respir Physiol Neurobiol. 2005 May 12;147(1):39-49. doi: 10.1016/j.resp.2005.01.003.
Other Identifiers
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IndonesiaUAnes039
Identifier Type: -
Identifier Source: org_study_id
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