NCT04029662

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

First Submitted

Initial submission to the registry

July 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

4 months

First QC Date

July 20, 2019

Last Update Submit

December 30, 2019

Conditions

Undefined

Outcome Measures

Primary Outcomes (1)

  • Level of Pain Intensity

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

    15 minutes

Study Arms (2)

Group Valsalva Maneuver

EXPERIMENTAL

Patients who undergo spinal anesthesia and perform Valsalva maneuver to reduce the pain intensity

Behavioral: Valsalva Maneuver

Group Control

NO INTERVENTION

Patients who undergo spinal anesthesia and perform nothing to reduce the pain intensity

Interventions

Valsalva ManeuverBEHAVIORAL

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

Group Valsalva Maneuver

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indonesia University

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (6)

  • 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: 15549987BACKGROUND

  • 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: 16192551BACKGROUND

  • 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: 28526468BACKGROUND

  • 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: 26662857BACKGROUND

  • Macfie AG, Brimacombe J. Response to the Valsalva manoeuvre after spinal anaesthesia. Anaesthesia. 1992 Jan;47(1):13-6. doi: 10.1111/j.1365-2044.1992.tb01944.x.

    PMID: 1536394BACKGROUND

  • Looga R. The Valsalva manoeuvre--cardiovascular effects and performance technique: a critical review. Respir Physiol Neurobiol. 2005 May 12;147(1):39-49. doi: 10.1016/j.resp.2005.01.003.

    PMID: 15848122BACKGROUND

MeSH Terms

Interventions

Valsalva Maneuver

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
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2019

First Posted

July 23, 2019

Study Start

August 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)