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

NCT ID: NCT04029662

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2019-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Undefined

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group Valsalva Maneuver

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

Group Type EXPERIMENTAL

Valsalva Maneuver

Intervention Type BEHAVIORAL

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

Group Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Valsalva Maneuver

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Alfan Mahdi Nugroho

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alfan M Nugroho, MD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Indonesia University

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 15549987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16192551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28526468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26662857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1536394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15848122 (View on PubMed)

Other Identifiers

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IndonesiaUAnes039

Identifier Type: -

Identifier Source: org_study_id

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