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CompletedNCT04029662Updated Jan 2, 2020

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

An interventional study of Valsalva Maneuver in Undefined, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-02.

Sponsored by Indonesia University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Undefined

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03

In context

Pain

2,219 studies on the registry are indexed under Pain; 917 are open to participants now.

This study's enrollment of 78 is above the median of 70 across 1,904 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Group Valsalva Maneuver

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

    Behavioral: Valsalva Maneuver

  • No intervention
    Group Control

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

Interventions

  • BehavioralValsalva Maneuver

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

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What researchers measure

Primary outcomes

  1. Level of Pain Intensity

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

    Time frame: 15 minutes

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Study locations

1 site
  • Indonesia University
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
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References and documents

Publications

  • 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. PubMed 15549987 ↗
  • 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. PubMed 16192551 ↗
  • 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. PubMed 28526468 ↗
  • 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. PubMed 26662857 ↗
  • 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. PubMed 1536394 ↗
  • 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. PubMed 15848122 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04029662
Lead sponsor
Indonesia University
Responsible party
Alfan Mahdi Nugroho (Principal Investigator, Indonesia University) — Principal investigator
First posted
Jul 23, 2019
Start date
Aug 1, 2019
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019
Last update
Jan 2, 2020

Study contacts

Alfan M Nugroho, MD
principal investigator · Indonesia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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