Adult Patient Undergoing Elective Surgery With Spinal AnesthesiaNCT03134391
Comparison Between Vapocoolant Spray and Eutectic Mixture of Local Anesthetics in Reducing Pain From Spinal Injection
A study testing Vapocoolant spray, EMLA in people with Adult Patient Undergoing Elective Surgery With Spinal Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aimed to evaluate the effect of vapocoolant spray and EMLA in reducing pain from spinal injection Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adult Patient Undergoing Elective Surgery With Spinal Anesthesia
- What is being tested?
- Vapocoolant spray, EMLA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2016to 31 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
This study aimed to evaluate the effect of vapocoolant spray and EMLA in reducing pain from spinal injection
Read the 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.
- Being tested
- Vapocoolant spray, EMLA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vapocoolant spray, EMLADrug
Subjects were given vapocoolant spray to reduce pain from spinal injection; subjects were given EMLA to reduce pain from spinal injection
| Study group | Role | What they receive |
|---|---|---|
| vapocoolant spray | Active comparator | Subjects received Vapocoolant spray before spinal anesthesia Receives: Drug: Vapocoolant spray, EMLA |
| EMLA | Active comparator | Subjects received EMLA before spinal anesthesia Receives: Drug: Vapocoolant spray, EMLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual Analog Scale for measuring pain
Measured: Day 1
Vital signs
Vital signs for measuring pain indirectly
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Aug 2016
- Primary completion30 Oct 2016
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adult Patient Undergoing Elective Surgery With Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riyadh Firdaus, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134391
- Sponsor's protocol ID
- IndonesiaUAnes012
- Status last verified
- Aug 2017
- First submitted
- 25 Apr 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25031805Bujedo 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.
PubMed 22798178Kim 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.
PubMed 19430559
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Vapocoolant Spray and Eutectic Mixture of Local Anesthetics in Reducing Pain From Spinal Injection
- ClinicalTrials.gov ID
- NCT03134391
- Acronym / sponsor ID
- IndonesiaUAnes012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vapocoolant spray | Active comparator | Drug: Vapocoolant spray, EMLASubjects received Vapocoolant spray before spinal anesthesia |
| EMLA | Active comparator | Drug: Vapocoolant spray, EMLASubjects received EMLA before spinal anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vapocoolant spray, EMLASubjects were given vapocoolant spray to reduce pain from spinal injection; subjects were given EMLA to reduce pain from spinal injection | Drug | EMLA, vapocoolant spray |
Primary outcome
VAS
Time frame: Day 1
Visual Analog Scale for measuring pain
Vital signs
Time frame: day 1
Vital signs for measuring pain indirectly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Background: PubMed 25031805Bujedo 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.
- Background: PubMed 22798178Bujedo 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.
- Results publication: PubMed 19430559Kim 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vapocoolant spray, EMLA in people with Adult Patient Undergoing Elective Surgery With Spinal Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03134391, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.