PregnantNCT01307839
Lidocaine Patch for Relief of Pain During Epidural Placement in Laboring Patients
A study testing 5% lidocaine patch in people with Pregnant and Labor, run by Loma Linda University at 1 site in United States.
Trial summary
Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural placement in laboring parturients1. Skin infiltration, although brief, can be very stressful and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing the pain and decreasing the satisfaction with… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- 5% lidocaine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Apr 2012
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Laboring patients between the ages of 18 and 45 with a BMI of less than 45
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Trial of the Lidocaine Patch for Relief of Pain During Epidural Needle Insertion in Laboring Patients
Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural placement in laboring parturients1. Skin infiltration, although brief, can be very stressful and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing the pain and decreasing the satisfaction with the procedure. To reduce this discomfort, various topical alternatives have been investigated with varying degrees of success.1-4 Now that a topical mixture of lidocaine that is safe and effective is available, the investigators would like to determine if it can reduce the pain of skin infiltration in particular and epidural placement as a whole.
- Being tested
- 5% lidocaine patch, placebo patch
- Keywords
- labor, epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% lidocaine patchDrug
Research intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours.
placebo patchDrug
Research intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours
| Study group | Role | What they receive |
|---|---|---|
| 5% lidocaine patch | Active comparator | If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back. Receives: Drug: 5% lidocaine patch |
| placebo patch | Placebo comparator | If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back. Receives: Drug: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the 5% lidocaine patch can decrease the pain from epidural placement.
Measured: a minimum of 30 minutes from patch placement and a maximum of 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Why it stopped: Study was stopped due to non-availability of the lidocaine placebo patches.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnantStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Applegate, Loma Linda University
- Investigators
- Richard L Applegate, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307839
- Sponsor's protocol ID
- 5110014
- Status last verified
- Apr 2012
- First submitted
- 1 Mar 2011
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of the Lidocaine Patch for Relief of Pain During Epidural Needle Insertion in Laboring Patients
- ClinicalTrials.gov ID
- NCT01307839
- Acronym / sponsor ID
- 5110014
- Keywords
- labor, epidural
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was stopped due to non-availability of the lidocaine placebo patches.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 3 Mar 2011 (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.
Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural placement in laboring parturients1. Skin infiltration, although brief, can be very stressful and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing the pain and decreasing the satisfaction with the procedure. To reduce this discomfort, various topical alternatives have been investigated with varying degrees of success.1-4 Now that a topical mixture of lidocaine that is safe and effective is available, the investigators would like to determine if it can reduce the pain of skin infiltration in particular and epidural placement as a whole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% lidocaine patch | Active comparator | Drug: 5% lidocaine patchIf the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back. |
| placebo patch | Placebo comparator | Drug: placebo patchIf the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Laboring patients between the ages of 18 and 45 with a BMI of less than 45
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 5% lidocaine patchResearch intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours. | Drug | 5% lidocaine patch |
| placebo patchResearch intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours | Drug | placebo patch |
Primary outcome
To determine if the 5% lidocaine patch can decrease the pain from epidural placement.
Time frame: a minimum of 30 minutes from patch placement and a maximum of 12 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
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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.
Richard L Applegate, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% lidocaine patch in people with Pregnant and Labor, run by Loma Linda University at 1 site in United States.
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 1 inclusion and 0 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: withdrawn, as of the sponsor's last update on 12 Apr 2012. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To determine if the 5% lidocaine patch can decrease the pain from epidural placement. (time frame: a minimum of 30 minutes from patch placement and a maximum of 12 hours). 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 12 Apr 2012.