We Focus on the Pain of Venipuncture and Intravenous CannulationPhase 2/3NCT02061475
Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation
A Phase 2/3 study testing Lidocaine Patches in people with We Focus on the Pain of Venipuncture and Intravenous Cannulation, run by RenJi Hospital at 8 sites in China.
Trial summary
Venipuncture and intravenous cannulation are the most common painful procedures, especially for the penitents who must receive large diameter venous catheter before surgery. In present study we would evaluate the safety and validity of lidocaine patches releasing such pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- We Focus on the Pain of Venipuncture and Intravenous Cannulation
- What is being tested?
- Lidocaine Patches
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 8 sitesChina
- Study dates
- Apr 2014to Mar 2015
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who want to participate present study and sign the informed consent form
- Age from 18 to 65 years old
- Patients who need intravenous cannulation before surgery
- ASA class I-II and selected patients
Who cannot join
- Allergic to lidocaine or any other amide local anesthetics or any other medicine
- Allergic skin(allergic to past agent or other topical used medicine)
- Skin injured or inflection exist in the local site to patch
- Sensation disturbed in any limb
- Severe liver and kidney original disease:blood Aspertate aminotransferase and Alanine transaminase increased 1.5 times more than normal concentration; blood creatinine is higher than the normal range.
- Hemoglobin <80g/L
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- ECG is significantly abnormal
- pregnant or possible pregnant or breastfeeding woman
- Patient who has consciousness disturbance can not make credible dialog with investigator.
- Those who are using other medicine may affect the evaluation of present patch
- Those who have participated in other clinical trail in the past three months
- Those excluded by investigator believed other reasons.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Xinmin Wu, Dr., 0086-10-83572784
Xinmin Wu, Dr.
- Recruiting
Xiangya Hospital Central South University
Changhai, Hunan, 410008
Qulian Guo, Dr., 0086-731-84327411
Qulian Guo, Dr.
- Recruiting
Guanzhou First people's Hospital
Guangzhou, Guangdong, 510180
Lixin Xu, Dr., 0086-20-81048305
Lixin Xu, Dr.
- Recruiting
Zhongshan Hospital Affiliated to Shanghai Fudan University
Shanghai, Shanghai Municipality, 200032
Zhanggang Xue, Dr., 0086-21-64041990 ext. 3702
Zhanggang Xue, Dr.
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
Diansan Su, Dr., diansansu@yahoo.com
Yanhua Zhao, Dr.
- Recruiting
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 201620
Shitong Li, Dr., 0086-21-63240090 ext. 3023
Shitong Li, Dr.
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Xiuying Wu, Dr., 0086-24-83955027
Xiuying Wu, Dr.
- Recruiting
The First Affiliate Hospital of Soochow University
Suzhou, Jiangsu, 215006
Jianping Yang, Dr., 0086-512-67780149
Jianping Yang, Dr.
About this study
Official title: The Efficacy and Safety of Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation Before Surgery: a Multicenter, Randomized, Double -Blind, Placebo-controled and Parallel-group Designed Clinical Trail
Venipuncture and intravenous cannulation are the most common painful procedures, especially for the penitents who must receive large diameter venous catheter before surgery. In present study we would evaluate the safety and validity of lidocaine patches releasing such pain.
- Being tested
- Lidocaine Patches
- Keywords
- Lidocaine patches, Pain, Intravenous cannulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine PatchesDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Patches | Active comparator | Not described Receives: Drug: Lidocaine Patches |
| Placebo Patches | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficiency of lidocaine patches for attenuating the pain of venipuncture intravenous cannulation before surgery
VAS score will be evaluated two minters after intravenous cannulation in both group with lidocaine patches or not.
Measured: Two minters after intravenous cannulation
Skin response after intravenous cannulation
Local skin response to the lidocaine patches will be evaluated thirty minters after intravenous cannulation
Measured: Thirty minters after intravenous cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for We Focus on the Pain of Venipuncture and Intravenous CannulationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nitto Denko Corporation, Giant Med-Pharma Services Inc.
- Responsible party
- Sponsor
- Investigators
- Diansan Su, Dr., Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong UniversityXiangrui Wang, Dr., Study chair, Renji Hospital, School of Medicine, Shanghai Jiaotong UniversityYanhua Zhao, Dr., Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061475
- Sponsor's protocol ID
- LCLDKY-13115
- Status last verified
- Jun 2014
- First submitted
- 11 Feb 2014
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation Before Surgery: a Multicenter, Randomized, Double -Blind, Placebo-controled and Parallel-group Designed Clinical Trail
- ClinicalTrials.gov ID
- NCT02061475
- Acronym / sponsor ID
- LCLDKY-13115
- Keywords
- Lidocaine patches, Pain, Intravenous cannulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Nitto Denko Corporation, Giant Med-Pharma Services Inc.
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 12 Feb 2014 (estimated)
- 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.
Venipuncture and intravenous cannulation are the most common painful procedures, especially for the penitents who must receive large diameter venous catheter before surgery. In present study we would evaluate the safety and validity of lidocaine patches releasing such pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Patches | Active comparator | Drug: Lidocaine Patches |
| Placebo Patches | Placebo comparator | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who want to participate present study and sign the informed consent form
- Age from 18 to 65 years old
- Patients who need intravenous cannulation before surgery
- ASA class I-II and selected patients
Key exclusion criteria (12 listed)
- Allergic to lidocaine or any other amide local anesthetics or any other medicine
- Allergic skin(allergic to past agent or other topical used medicine)
- Skin injured or inflection exist in the local site to patch
- Sensation disturbed in any limb
- Severe liver and kidney original disease:blood Aspertate aminotransferase and Alanine transaminase increased 1.5 times more than normal concentration; blood creatinine is higher than the normal range.
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 |
|---|---|---|
| Lidocaine Patches | Drug | Lidocaine Patches |
Primary outcome
The efficiency of lidocaine patches for attenuating the pain of venipuncture intravenous cannulation before surgery
Time frame: Two minters after intravenous cannulation
VAS score will be evaluated two minters after intravenous cannulation in both group with lidocaine patches or not.
Skin response after intravenous cannulation
Time frame: Thirty minters after intravenous cannulation
Local skin response to the lidocaine patches will be evaluated thirty minters after intravenous cannulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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.
Diansan Su, Dr. principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Xiangrui Wang, Dr. study chair
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Yanhua Zhao, Dr. principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lidocaine Patches in people with We Focus on the Pain of Venipuncture and Intravenous Cannulation, run by RenJi Hospital at 8 sites in China.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Dr. (0086-21-68383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficiency of lidocaine patches for attenuating the pain of venipuncture intravenous cannulation before surgery (time frame: Two minters after intravenous cannulation). 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?
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 29 Aug 2014.