Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

Brachytherapy Clinical Trial

Official title:

Comparison of Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215276
• Other study ID #: IndonesiaUAnes 048
• Status: Completed
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: April 26, 2019

Study information

• Verified date: February 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brachytherapy

Intervention

Other:
• Valsalva maneuver
pressure during Valsalva maneuver was measure using sphygmomanometer
• Control
patient was not given any intervention

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

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):1230-2, table of contents. — View Citation

Calthorpe N. The history of spinal needles: getting to the point. Anaesthesia. 2004 Dec;59(12):1231-41. — View Citation

Çigdem ÜK, Sevinç S, Esef B, Süreyya Ö, 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.20 — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measurement during injection with VAS score	Pain degree was measured with VAS score [0 equals to no pain whereas 10 equals to the maximum pain]	30 seconds
Secondary	Patient movement	Investigator observes patient movement during the first spinal injection	30 seconds