Skip to main content
OpenTrials
Completed

NCT Number: NCT04029662

Reducing Pain Intensity During Spinal Needle Insertion: Valsalva Maneuver vs. Control Technique

This study was aimed to observe the efficacy of Valsalva maneuver in reducing pain intensity during spinal needle insertion.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Undefined

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indonesia University

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

Spinal anesthesia is one of the regional anesthesia techniques needed to provide motor, sensory, and autonomic blocks specifically for lower limbs by delivering local anesthetics into subarachnoid space. This technique is not difficult to perform and relatively inexpensive. However, spinal anesthesia may cause an intense pain during needle insertion. Valsalva maneuver is an attempt to force expiration by pushing a closed airway, such as covering nose or mouth. This maneuver can lead to anti-nociceptive stimulation and may decrease the pain. Thus, this study was aimed to observe the efficacy of Valsalva maneuver in reducing pain intensity during spinal needle insertion.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Elective patients having spinal anesthesia
  • 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 contraindications of spinal anesthesia
  • Patients with difficulty in blowing 30 mmHg for 20 seconds
  • Patients having allergic reactions due to local anesthetics and opioid

Treatment and study plan

Valsalva Maneuver

Behavioral

Performing Valsalva maneuver will reduce the pain intensity during spinal needle insertion.

Primary outcomes

  1. Level of Pain Intensity

    Time frame: 15 minutes

    Pain Measurement by Visual Analog Scale or Numeric Rating Scale with Range 1-10

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison of Valsalva Maneuver and Control Technique in Reducing Pain Intensity During Spinal Needle Insertion

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2019
Registry last updated
Jan 2, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.