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

Not Applicable

Completed

• Conditions: Undefined
• Interventions: Behavioral: Valsalva Maneuver

• Registration Number: NCT04029662
• Lead Sponsor: Indonesia University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-07-20
• Study First Submitted QC: 2019-07-20
• Study First Posted: 2019-07-23
• Study Start: 2019-08-01
• Status Verified: 2019-12
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-30
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Valsalva Maneuver	Valsalva Maneuver	Patients who undergo spinal anesthesia and perform Valsalva maneuver to reduce the pain intensity

Primary Outcome Measures

Name	Time	Method
Level of Pain Intensity	15 minutes	Pain Measurement by Visual Analog Scale or Numeric Rating Scale with Range 1-10

Trial Locations

Locations (1)

Indonesia University; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia