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Clinical Trials/NCT03134391
NCT03134391
Completed
N/A

Comparison Between Vapocoolant Spray and Eutectic Mixture of Local Anesthetics in Reducing Pain From Spinal Injection

Indonesia University1 site in 1 country97 target enrollmentAugust 1, 2016

Overview

Phase
N/A
Intervention
Vapocoolant spray, EMLA
Conditions
Adult Patient Undergoing Elective Surgery With Spinal Anesthesia
Sponsor
Indonesia University
Enrollment
97
Locations
1
Primary Endpoint
Vital signs
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study aimed to evaluate the effect of vapocoolant spray and EMLA in reducing pain from spinal injection

Detailed Description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Vapocoolant spray group and eutectic mixture local anesthetics (EMLA) group). Intravenous (IV) cannulae with Ringer Acetate fluid, non-invasive blood pressure monitor, and pulse-oxymetry were set on the subjects in the operation room. Vital signs were recorded. Patients were positioned in sitting position and were instructed to flex their head and bend their back. Identification of intervertebral space L4-5 were performed. Asepsis and antisepsis procedure were performed. The Vapocoolant spray group received vapocoolant spray at a distance of 10 cm for 2 seconds and we waited for 10 seconds. The EMLA group received EMLA cream which consisted of 2.5% lidocaine and 2.5 % prilocaine in 2 ml of water/oil emulsion and then they received tegaderm as the dressing for 45-60 minutes before the cream was wiped off. Spinal injection using 27G needle were performed after the intervention to each groups. Needle bevels were aligned parallel to dura fibres. Patients' visual analog score (VAS) and movements were recorded. Evaluation was only done in the first injection attempt, and was followed until the depth of the needle was around 5 mm. After the injection was successfully performed, patients' position were changed into supine position. Evaluation and recording were performed by person who was blinded from the intervention. Vital signs were recorded for every 3 minutes in the first 15 minutes, and then every 5 minutes until the end of the procedure.

Registry
clinicaltrials.gov
Start Date
August 1, 2016
End Date
May 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Riyadh Firdaus

Anesthesiologist Consultant

Indonesia University

Eligibility Criteria

Inclusion Criteria

  • woman aged \>18 years old
  • American Society of Anesthesiologists (ASA) physical status I-III who were planned to undergo one-day care elective surgery at operating room in spinal anesthesia
  • patients who were planned to undergo brachytherapy

Exclusion Criteria

  • Subjects with history of allergy to anesthetic agents
  • unstable hemodynamic
  • history of active psychotropic drug consumption
  • spinal anesthesia contraindications such as local infection, severe coagulopathy, severe hypovolemia, or increased intracranial pressure

Arms & Interventions

vapocoolant spray

Subjects received Vapocoolant spray before spinal anesthesia

Intervention: Vapocoolant spray, EMLA

EMLA

Subjects received EMLA before spinal anesthesia

Intervention: Vapocoolant spray, EMLA

Outcomes

Primary Outcomes

Vital signs

Time Frame: day 1

Vital signs for measuring pain indirectly

VAS

Time Frame: Day 1

Visual Analog Scale for measuring pain

Study Sites (1)

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