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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
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
July 20, 2019
Last Updated
December 30, 2019
Sponsor
Indonesia University
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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
No
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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