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

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

Study Overview

• Status: Completed
• Conditions: Adult Patient Undergoing Elective Surgery With Spinal Anesthesia
• Intervention / Treatment: Drug: Vapocoolant spray, EMLA

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Cental National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	Visual Analog Scale for measuring pain	Day 1
Vital signs	Vital signs for measuring pain indirectly	day 1

Collaborators and Investigators

• Sponsor: Indonesia University

Publications and helpful links

General Publications

• Bujedo BM. Current evidence for spinal opioid selection in postoperative pain. Korean J Pain. 2014 Jul;27(3):200-9. doi: 10.3344/kjp.2014.27.3.200. Epub 2014 Jun 30.
• Bujedo BM, Santos SG, Azpiazu AU. A review of epidural and intrathecal opioids used in the management of postoperative pain. J Opioid Manag. 2012 May-Jun;8(3):177-92. doi: 10.5055/jom.2012.0114.
• Kim SH, Jeon DH, Chang CH, Lee SJ, Shin YS. Spinal anesthesia with isobaric tetracaine in patients with previous lumbar spinal surgery. Yonsei Med J. 2009 Apr 30;50(2):252-6. doi: 10.3349/ymj.2009.50.2.252.

Helpful Links

• Ripamonti CI. Pain management. Ann Oncol. 2012 Sep;23 Suppl 10:x294- 301.
• Kim YJ, Jung MH, Choi YR, Park HJ, Won RS, Lee JY, et al. The analgesic efficacy of a 5% eutectic mixture of lidocaine and prilocaine prior to insertion of spinal and epidural block. Korean J of Anesthesiol. 2008;54(4):395-9.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): October 30, 2016
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IndonesiaUAnes012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No