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

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

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

Study Overview

• Status: Completed
• Conditions: Undefined
• Intervention / Treatment: Behavioral: Valsalva Maneuver

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Indonesia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Valsalva Maneuver; Patients who undergo spinal anesthesia and perform Valsalva maneuver to reduce the pain intensity	Behavioral: Valsalva Maneuver; Performing Valsalva maneuver will reduce the pain intensity during spinal needle insertion.
No Intervention: Group Control; Patients who undergo spinal anesthesia and perform nothing to reduce the pain intensity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Pain Intensity	Pain Measurement by Visual Analog Scale or Numeric Rating Scale with Range 1-10	15 minutes

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Alfan M Nugroho, MD, Indonesia University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 20, 2019
• First Submitted That Met QC Criteria: July 20, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain
• Other Study ID Numbers: IndonesiaUAnes039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No