NCT04215276

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

December 30, 2019

Last Update Submit

February 19, 2020

Conditions

Brachytherapy

Keywords

valsalva maneuvercontrolpainspinal injection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient movement

    30 seconds

Study Arms (2)

Valsalva Maneuver

ACTIVE COMPARATOR

Patient will do valsalva maneuver for 20 seconds

Other: Valsalva maneuver

control

PLACEBO COMPARATOR

Patient will do nothing

Other: Control

Interventions

Valsalva maneuverOTHER

pressure during Valsalva maneuver was measure using sphygmomanometer

Valsalva Maneuver
ControlOTHER

patient was not given any intervention

control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients underwent elective surgery using spinal anesthesia
  • patients who have not undergone spinal anesthesia before
  • Physical status ASA I or II
  • Signing informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (5)

  • Calthorpe N. The history of spinal needles: getting to the point. Anaesthesia. 2004 Dec;59(12):1231-41. doi: 10.1111/j.1365-2044.2004.03976.x.

    PMID: 15549987RESULT

  • 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.2016.69.1.27. Epub 2016 Jan 28.

    PMID: 26885298RESULT

  • 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):1230-1232. doi: 10.1213/01.ane.0000167270.15047.49.

    PMID: 16192551RESULT

  • Cigdem UK, Sevinc S, Esef B, Sureyya O, 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.2017.04.011. Epub 2017 May 16. Portuguese.

    PMID: 28526468RESULT

  • 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.

    PMID: 26662857RESULT

MeSH Terms

Conditions

Pain

Interventions

Valsalva Maneuver

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespiratory Physiological Phenomena

Study Officials

  • Alfan M Nugroho, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 2, 2020

Study Start

January 21, 2019

Primary Completion

April 26, 2019

Study Completion

April 26, 2019

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)