Clinical trial NCT04215276: Valsalva Maneuver and Control in Reducing Pain During Spinal Injection
Official title: Comparison of Valsalva Maneuver and Control in Reducing Pain During Spinal Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brachytherapy
Keywords: valsalva maneuver
control
pain
spinal injection
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to compare the effectiveness of Valsalva maneuver as non pharmacological approach and control in reducing pain during spinal injection.

Detailed description: This was an experimental study on 70 subjects with 35 subjects treated with Valsalva maneuver and 35 subjects treated as control from January to April 2019. Research subjects were female who underwent brachytherapy for the first time with spinal anesthesia. The effectiveness in reducing pain was assessed by using Visual Analogue Scale (VAS) and patient movement during the surgery.

Eligibility criteria: Inclusion Criteria:

* patients underwent elective surgery using spinal anesthesia
* patients who have not undergone spinal anesthesia before
* Physical status ASA I or II
* Signing informed consent

Exclusion Criteria:

* have a spinal anesthesia history
* contraindicated for spinal anesthesia
* subjects who cannot do Valsalva to 30mmHg pressure for 20 seconds
* have a allergic history to local anesthetics or opioid drugs

Primary outcomes:
measure: Pain measurement during injection with VAS score
timeFrame: 30 seconds
Secondary outcomes:
measure: Patient movement
timeFrame: 30 seconds
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo National Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Alfan M Nugroho, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kumar S, Gautam SK, Gupta D, Agarwal A, Dhirraj S, Khuba S. The effect of Valsalva maneuver in attenuating skin puncture pain during spinal anesthesia: a randomized controlled trial. Korean J Anesthesiol. 2016 Feb;69(1):27-31. doi: 10.4097/kjae.2016.69.1.27. Epub 2016 Jan 28.
citation: 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.
citation: 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.
citation: 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.