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The aim of this study is to investigate the impact of using lidocaine patches after cesarean section on pain control and opioid use in the immediate post-operative period. The hypothesis is the use of lidocaine patches in the immediate post-operative period will lead to a decrease in the visual analog pain score compared to women who do not use a lidocaine patch in the immediate post-operative period following cesarean delivery. Additionally, a decrease in the use of opioids as pain control compared to patients that do not have a lidocaine patch in place the is anticipated.
The use of lidocaine as a local anesthetic is a common and widely used in practice. Lidocaine patches can be used for localized pain control and can be placed every 24 hours. The use of lidocaine patches in post-operative patients has been reported in one case report in obstetric literature. There is one study that reports decreased immediate postoperative pain when lidocaine patches were placed at laparoscopic port sites following gynecologic surgery as measured by visual analog scale score and the Prince Henry and 5-point verbal rating pain scale. There have been no studies looking at the impact of lidocaine patches in obstetric surgical procedures, specifically cesarean sections.
Cesarean sections are one of the most common surgeries in the United States. Following cesarean sections it is common to utilize opioids in the hospital and upon discharge to manage patient's post-operative pain. According to the CDC overdose deaths involving prescription opioids were five times higher in 2017 than in 1999 with over 200,000 deaths. This creates an opportunity to decrease the use of post-operative opioids with the application of a lidocaine patch as an adjunctive post-operative pain management modality following cesarean sections.
Lidocaine patches are a common topical analgesia therapy used for localized pain control in the inpatient and outpatient setting. It's use in the postoperative period is less understood and the use of topical lidocaine patches has not been thoroughly investigated in the surgical literature. Thus far, it has been shown as an effective therapy at laparoscopic port sites following laparoscopic appendectomies. It's use in obstetrical surgeries has not been studied. Overall, the limited research on this topic making it a valuable area of research.
This study will involve prospective enrollment of women undergoing cesarean deliveries. Women will be randomized to receive a lidocaine patch or no lidocaine patch to be worn for 72 hours after delivery to help manage postoperative pain. This will be an adjunctive therapy in addition to the parental and oral narcotic pain medication that is routine prescribed. The utility of lidocaine patches for management of post-cesarean delivery pain will be assess by 2 measures. The first measure will involve the total daily dose of narcotic used in morphine equivalent doses. The second outcome assessed will be subjective pain as measured on a 1-10 scale and reported by the patients to nursing staff. This score will be averaged for each 24 hour period post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine Patch Group | Experimental | This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management. |
|
| Control Group | Placebo Comparator | This group will be women randomized to routine postoperative pain management following cesarean delivery. A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine patch | Drug | Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Pain Score | Daily pain scores conducted by the nursing staff every morning and prior to medication administration. This will be a repeated measure using the subjective 0-10 pain scale. The scores will be averaged over each 24 hour (day) period and then compared. Lower scores indicate less pain. | the first 72 hours post-operative, up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Use | The total average milligrams of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents | the first 72 hours post-operative |
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Inclusion Criteria:
Exclusion Criteria:
Patients need to be pregnant and undergoing a cesarean delivery
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| Name | Affiliation | Role |
|---|---|---|
| Audrey Merriam, MD, MS | Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences | Principal Investigator |
| Christopher Arkfeld, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06512 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22715181 | Background | Gilhooly D, McGarvey B, O'Mahony H, O'Connor TC. Topical lidocaine patch 5% for acute postoperative pain control. BMJ Case Rep. 2011 Feb 8;2011:bcr0620103074. doi: 10.1136/bcr.06.2010.3074. | |
| 22861076 | Background | Kwon YS, Kim JB, Jung HJ, Koo YJ, Lee IH, Im KT, Woo JS, Im KS. Treatment for postoperative wound pain in gynecologic laparoscopic surgery: topical lidocaine patches. J Laparoendosc Adv Surg Tech A. 2012 Sep;22(7):668-73. doi: 10.1089/lap.2011.0440. Epub 2012 Aug 3. |
| Label | URL |
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| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine Patch Group | This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management. Lidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management |
| FG001 | Control Group | This group will be women randomized to routine postoperative pain management following cesarean delivery. A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine Patch Group | This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management. Lidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Pain Score | Daily pain scores conducted by the nursing staff every morning and prior to medication administration. This will be a repeated measure using the subjective 0-10 pain scale. The scores will be averaged over each 24 hour (day) period and then compared. Lower scores indicate less pain. | Posted | Mean | Standard Deviation | score on a scale | the first 72 hours post-operative, up to 4 days |
|
the first 72 hours post-operative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine Patch Group | This group will be women who were randomized to receive a lidocaine patch for postoperative pain following cesarean delivery in addition to routine postoperative pain management. Lidocaine patch: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Arkfeld | Massachusetts General Hospital | 4029803860 | carkfeld@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2021 | Aug 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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This will be a prospective randomized non-blinded controlled trial. All cesarean sections for women undergoing their first or second cesarean delivery will be included. Patients will be approached and consented during the pre-operative period when presenting for scheduled surgery or at the time of consent for a non-scheduled cesarean section. The lidocaine patch would be placed on the superior-lateral aspect of the Pfannenstiel incision in the PACU prior to being transferred to the postpartum floor.
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Outcomes assessor/statistician will not be made aware of the treatment group of the patients.
| Placebo patch | Other | A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group. |
|
| BG001 |
| Control Group |
This group will be women randomized to routine postoperative pain management following cesarean delivery. A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Prepregnancy Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| BMI at Delivery | Mean | Standard Deviation | kg/m^2 |
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| Gravidity | The number of times a woman has been pregnant, regardless of whether the pregnancies were interrupted or resulted in a live birth. | Mean | Standard Deviation | pregnancies |
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| Parity Term | Number of births a female has had after 20 weeks gestation. | Mean | Standard Deviation | births |
|
| Parity Preterm | Number of births a female has had before 20 weeks gestation. | Mean | Standard Deviation | births |
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| Parity Abortions | Number of births a female has had resulting in abortions. | Mean | Standard Deviation | births |
|
| Parity Living Children | Number of births a female has had resulting in living children. | Mean | Standard Deviation | births |
|
| Gestational Age at Delivery | Mean | Standard Deviation | weeks |
|
| Number of Previous C-sections | Mean | Standard Deviation | c-sections |
|
This group will be women randomized to routine postoperative pain management following cesarean delivery. A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group. |
|
|
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| Secondary | Narcotic Use | The total average milligrams of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents | Posted | Mean | Standard Deviation | mg morphine equivalents | the first 72 hours post-operative |
|
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Control Group | This group will be women randomized to routine postoperative pain management following cesarean delivery. | 0 | 47 | 0 | 47 | 0 | 47 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |