Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

University of Indonesia (UI)

Status: Completed

Conditions: Brachytherapy

Treatments: Other: Valsalva maneuver; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04215276

IndonesiaUAnes 048

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups, including a placebo group

Valsalva Maneuver

Active Comparator group

Description:

Patient will do valsalva maneuver for 20 seconds

Treatment:

Other: Valsalva maneuver

control

Placebo Comparator group

Description:

Patient will do nothing

Treatment:

Other: Control