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

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ClinicalTrials.gov Identifier: NCT03134391
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Riyadh Firdaus, Indonesia University

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

Condition or disease Intervention/treatment Phase
Adult Patient Undergoing Elective Surgery With Spinal Anesthesia Drug: Vapocoolant spray, EMLA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison Between Vapocoolant Spray and Eutectic Mixture of Local Anesthetics in Reducing Pain From Spinal Injection
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : October 30, 2016
Actual Study Completion Date : May 31, 2017

Arm Intervention/treatment
Active Comparator: vapocoolant spray
Subjects received Vapocoolant spray before spinal anesthesia
Drug: Vapocoolant spray, EMLA
Subjects were given vapocoolant spray to reduce pain from spinal injection; subjects were given EMLA to reduce pain from spinal injection

Active Comparator: EMLA
Subjects received EMLA before spinal anesthesia
Drug: Vapocoolant spray, EMLA
Subjects were given vapocoolant spray to reduce pain from spinal injection; subjects were given EMLA to reduce pain from spinal injection




Primary Outcome Measures :
  1. VAS [ Time Frame: Day 1 ]
    Visual Analog Scale for measuring pain

  2. Vital signs [ Time Frame: day 1 ]
    Vital signs for measuring pain indirectly



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Studies has shown that women have lower threshold for pain
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134391


Locations
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Indonesia
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Riyadh Firdaus, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier: NCT03134391     History of Changes
Other Study ID Numbers: IndonesiaUAnes012
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anesthetics
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Combined