Pain, PostoperativePhase 4NCT03500211

Post-Op Lidocaine Patch

A Phase 4 study testing Lidoderm 5 % Topical Patch in people with Pain, Postoperative, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain. Read more about this study

Who is it for?: Ages 18 to 89 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pain, Postoperative
What is being tested?: Lidoderm 5 % Topical Patch
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 13 Mar 2018to 1 Mar 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 89 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Pregnant patients who require a scheduled or non-urgent cesarean birth
Patient able to receive neuraxial analgesia
Patient able to give verbal and written consent for both cesarean birth and study

Who cannot join

Patients requiring emergent cesarean birth
Patients allergic to lidocaine or adhesive
Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth
Patients using chronic oral neuromodulators
Patients with cardiac disease or using anti-arrhythmic agents
Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus.
Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health and Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Lidocaine Patch for Adjunct Analgesia for Postoperative Cesarean Birth Patients

Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.

Read the detailed description

The purpose of this study is to determine if lidocaine patches decrease post-operative pain associated with cesarean births. While the Lidoderm lidocaine patch has been FDA approved for the treatment of skin pain, it has not been studied in women undergoing cesarean birth who experience postoperative pain. Even though this medication has been used in post-operative pain in published studies, the use of this medicine under these circumstances is still considered experimental. A lidocaine patch may provide added benefit for pain control in addition to standard medicines participants would receive after surgery, such as spinal, intravenous, and oral pain medications following cesarean delivery.

Conditions: Pain, Postoperative
Being tested: Lidoderm 5 % Topical Patch, Sham Topical Patch
Keywords: Cesarean section, Postoperative pain
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lidoderm 5 % Topical PatchDrug
Also called lidocaine patch
Lidocaine patch after cesarean section delivery.
Sham Topical PatchOther
Also called sham patch
Sham patch after cesarean section delivery.

Study groups in NCT03500211
Study group	Role	What they receive
Lidoderm 5% Topical Patch	Experimental	5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery. Receives: Drug: Lidoderm 5 % Topical Patch
Sham Topical Patch	Sham comparator	Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery. Receives: Other: Sham Topical Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

12-hour Postoperative Pain Scores
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 12 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Measured: Postoperative (12 hours)
24-hour Postoperative Pain Scores
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Measured: Postoperative (24 hours)
36-hour Postoperative Pain Scores
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 36 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Measured: Postoperative (36 hours)
48-hour Postoperative Pain Scores
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 48 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
Measured: Postoperative (48 hours)

Secondary outcomes (1)

5-days Postoperative Narcotic Use
To determine if narcotic use changes when patients use lidocaine patches by counting amount and frequency of narcotic use over admission. Average number of 5 mg oxycodone pills used in women who have undergone cesarean delivery assessed through questionnaire at 5 days postoperatively.
Measured: Postoperative (5 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 20181 Mar 2019

First posted18 Apr 2018
Study start13 Mar 2018
Primary completion1 Mar 2019
Study completion1 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain, PostoperativeStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03500211
Sponsor's protocol ID: OHSU IRB 16657
Status last verified: Feb 2020
First submitted: 9 Apr 2018
Last updated: 11 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain

All Pain, Postoperative trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lidocaine Patch for Adjunct Analgesia for Postoperative Cesarean Birth Patients
ClinicalTrials.gov ID: NCT03500211
Acronym / sponsor ID: OHSU IRB 16657
Conditions: Pain, Postoperative
Keywords: Cesarean section, Postoperative pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Study start: 13 Mar 2018 (actual)
Primary completion: 1 Mar 2019 (actual)
Study completion: 1 Mar 2019 (actual)
First posted: 18 Apr 2018 (actual)
Results: Posted 11 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lidoderm 5% Topical Patch	Experimental	Drug: Lidoderm 5 % Topical Patch5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
Sham Topical Patch	Sham comparator	Other: Sham Topical PatchSham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Who may qualify

Ages: 18 to 89 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Pregnant patients who require a scheduled or non-urgent cesarean birth
Patient able to receive neuraxial analgesia
Patient able to give verbal and written consent for both cesarean birth and study

Key exclusion criteria (7 listed)

Patients requiring emergent cesarean birth
Patients allergic to lidocaine or adhesive
Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth
Patients using chronic oral neuromodulators
Patients with cardiac disease or using anti-arrhythmic agents

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
Lidoderm 5 % Topical PatchAlso: lidocaine patchLidocaine patch after cesarean section delivery.	Drug	Lidoderm 5% Topical Patch
Sham Topical PatchAlso: sham patchSham patch after cesarean section delivery.	Other	Sham Topical Patch

Primary outcome

12-hour Postoperative Pain Scores
Time frame: Postoperative (12 hours)
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 12 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
24-hour Postoperative Pain Scores
Time frame: Postoperative (24 hours)
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
36-hour Postoperative Pain Scores
Time frame: Postoperative (36 hours)
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 36 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
48-hour Postoperative Pain Scores
Time frame: Postoperative (48 hours)
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 48 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

1 secondary outcome

5-days Postoperative Narcotic Use
Time frame: Postoperative (5 days)

Results and safety

Results posted to the registry on 11 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lidoderm 5% Topical Patch	25	24
Sham Topical Patch	25	24

Primary outcome: 12-hour Postoperative Pain Scores

Time frame: Postoperative (12 hours). Mean (Standard Deviation). Unit: score on a scale

Measure	Lidoderm 5% Topical Patch n = 25	Sham Topical Patch n = 25
Value	33.5 (17.0)	28.8 (21.8)

Primary outcome: 24-hour Postoperative Pain Scores

Time frame: Postoperative (24 hours). Mean (Standard Deviation). Unit: score on a scale

Measure	Lidoderm 5% Topical Patch n = 25	Sham Topical Patch n = 25
Value	34.1 (23.1)	32.9 (20.0)

Primary outcome: 36-hour Postoperative Pain Scores

Time frame: Postoperative (36 hours). Mean (Standard Deviation). Unit: score on a scale

Measure	Lidoderm 5% Topical Patch n = 24	Sham Topical Patch n = 24
Value	37.3 (13.4)	43.0 (22.8)

Primary outcome: 48-hour Postoperative Pain Scores

Time frame: Postoperative (48 hours). Mean (Standard Deviation). Unit: score on a scale

Measure	Lidoderm 5% Topical Patch n = 24	Sham Topical Patch n = 24
Value	24.8 (16.1)	29.6 (23.6)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 5 days post-operation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lidoderm 5% Topical Patch	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Sham Topical Patch	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pain, Postoperative

Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain

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.

Catherine Leclair, MD principal investigator

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidoderm 5 % Topical Patch in people with Pain, Postoperative, run by Oregon Health and Science 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 3 inclusion and 7 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 11 Mar 2020. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

12-hour Postoperative Pain Scores (time frame: Postoperative (12 hours)). The study lists 4 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 NCT03500211.

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 11 Mar 2020.