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

Primary Purpose

Undefined

Status

Completed

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Valsalva Maneuver

About this trial

This is an interventional supportive care trial for Undefined

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Indonesia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group Valsalva Maneuver

Group Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Level of Pain Intensity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04029662

First Posted

July 20, 2019

Last Updated

December 30, 2019

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT04029662

Brief Title

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

Official Title

Comparison of Valsalva Maneuver and Control Technique in Reducing Pain Intensity During Spinal Needle Insertion

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Undefined

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group Valsalva Maneuver

Arm Type

Experimental

Arm Description

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

Arm Title

Group Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Valsalva Maneuver

Intervention Description

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

Primary Outcome Measure Information:

Title

Level of Pain Intensity

Description

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

Time Frame

15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alfan M Nugroho, MD

Organizational Affiliation

Indonesia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indonesia University

City

Jakarta Pusat

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15549987

Citation

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.

Results Reference

background

PubMed Identifier

16192551

Citation

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.

Results Reference

background

PubMed Identifier

28526468

Citation

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.

Results Reference

background

PubMed Identifier

26662857

Citation

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.

Results Reference

background

PubMed Identifier

1536394

Citation

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.

Results Reference

background

PubMed Identifier

15848122

Citation

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.

Results Reference

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

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