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

Not Applicable

Completed

• Conditions: Adult Patient Undergoing Elective Surgery With Spinal Anesthesia
• Interventions: Drug: Vapocoolant spray, EMLA

• Registration Number: NCT03134391
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2016-10-30
• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-05-01
• Study Completion: 2017-05-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vapocoolant spray	Vapocoolant spray, EMLA	Subjects received Vapocoolant spray before spinal anesthesia
EMLA	Vapocoolant spray, EMLA	Subjects received EMLA before spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Vital signs	day 1	Vital signs for measuring pain indirectly
VAS	Day 1	Visual Analog Scale for measuring pain

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia