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Completed

NCT Number: NCT04215276

Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

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

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Key information

Conditions

Brachytherapy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valsalva maneuver

Other

pressure during Valsalva maneuver was measure using sphygmomanometer

Control

Other

patient was not given any intervention

Primary outcomes

  1. Pain measurement during injection with VAS score

    Time frame: 30 seconds

    Pain degree was measured with VAS score [0 equals to no pain whereas 10 equals to the maximum pain]

Secondary outcomes

  1. Patient movement

    Time frame: 30 seconds

    Investigator observes patient movement during the first spinal injection

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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