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

Undefined Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029662
• Other study ID #: IndonesiaUAnes039
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Undefined

Intervention

Behavioral:
• Valsalva Maneuver
Performing Valsalva maneuver will reduce the pain intensity during spinal needle insertion.

Locations

Country	Name	City	State
Indonesia	Indonesia University	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (6)

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):1230-2, table of contents. — View Citation

Calthorpe N. The history of spinal needles: getting to the point. Anaesthesia. 2004 Dec;59(12):1231-41. — View Citation

Çigdem ÜK, Sevinç S, Esef B, Süreyya Ö, 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. — View Citation

Looga R. The Valsalva manoeuvre--cardiovascular effects and performance technique: a critical review. Respir Physiol Neurobiol. 2005 May 12;147(1):39-49. Review. — View Citation

Macfie AG, Brimacombe J. Response to the Valsalva manoeuvre after spinal anaesthesia. Anaesthesia. 1992 Jan;47(1):13-6. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Pain Intensity	Pain Measurement by Visual Analog Scale or Numeric Rating Scale with Range 1-10	15 minutes