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Lidocaine Patches After Cesarean Section

Lidocaine Patches After Cesarean Section

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04443569
Acronym
LPACS
Enrollment
93
Registered
2020-06-23
Start date
2021-10-10
Completion date
2022-08-31
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Obstetric Pain, Opioid Use

Brief summary

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.

Detailed description

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.

Interventions

Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management

OTHERPlacebo patch

A placebo patch will be placed superior to the Pfannenstiel incision in the same manner as the lidocaine patch treatment group.

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessor/statistician will not be made aware of the treatment group of the patients.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
Yes

Inclusion criteria

* Female * Primary or secondary cesarean delivery * Able to consent to research study

Exclusion criteria

* 3 or more prior cesarean deliveries * History of abdominoplasty * History of abdominal hernia repair with mesh * Allergy to lidocaine * Allergy to adhesives in medical tape * Women who received general anesthesia for their cesarean delivery * Women with active substance abuse * Women methadone or suboxone for a history of opiate abuse

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Pain Scorethe first 72 hours post-operative, up to 4 daysDaily 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.

Secondary

MeasureTime frameDescription
Narcotic Usethe first 72 hours post-operativeThe total average milligrams of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents

Countries

United States

Participant flow

Participants by arm

ArmCount
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
46
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.
47
Total93

Baseline characteristics

CharacteristicLidocaine Patch GroupControl GroupTotal
Age, Continuous33.4 years
STANDARD_DEVIATION 3.9
33.5 years
STANDARD_DEVIATION 4.6
33.4 years
STANDARD_DEVIATION 4.3
BMI at Delivery35.3 kg/m^2
STANDARD_DEVIATION 6.9
34.5 kg/m^2
STANDARD_DEVIATION 6.7
34.9 kg/m^2
STANDARD_DEVIATION 6.8
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants13 Participants25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
34 Participants34 Participants68 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Gestational Age at Delivery38.6 weeks
STANDARD_DEVIATION 1
38.4 weeks
STANDARD_DEVIATION 1.3
38.5 weeks
STANDARD_DEVIATION 1.2
Gravidity3.2 pregnancies
STANDARD_DEVIATION 1.6
3.4 pregnancies
STANDARD_DEVIATION 2
3.3 pregnancies
STANDARD_DEVIATION 1.8
Number of Previous C-sections1 c-sections
STANDARD_DEVIATION 0.7
1.1 c-sections
STANDARD_DEVIATION 0.7
1.1 c-sections
STANDARD_DEVIATION 0.7
Parity Abortions0.9 births
STANDARD_DEVIATION 1.5
0.9 births
STANDARD_DEVIATION 1.2
0.9 births
STANDARD_DEVIATION 1.3
Parity Living Children1.4 births
STANDARD_DEVIATION 0.9
1.6 births
STANDARD_DEVIATION 0.9
1.5 births
STANDARD_DEVIATION 0.9
Parity Preterm0.2 births
STANDARD_DEVIATION 1.3
0.1 births
STANDARD_DEVIATION 0.3
0.2 births
STANDARD_DEVIATION 1
Parity Term1.3 births
STANDARD_DEVIATION 0.8
1.5 births
STANDARD_DEVIATION 0.9
1.4 births
STANDARD_DEVIATION 0.8
Prepregnancy Body Mass Index (BMI)30.4 kg/m^2
STANDARD_DEVIATION 7.8
29.6 kg/m^2
STANDARD_DEVIATION 6.6
30 kg/m^2
STANDARD_DEVIATION 7.2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants6 Participants9 Participants
Race (NIH/OMB)
Black or African American
8 Participants5 Participants13 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants3 Participants11 Participants
Race (NIH/OMB)
White
27 Participants33 Participants60 Participants
Region of Enrollment
United States
46 participants47 participants93 participants
Sex: Female, Male
Female
46 Participants47 Participants93 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 460 / 47
other
Total, other adverse events
0 / 460 / 47
serious
Total, serious adverse events
0 / 460 / 47

Outcome results

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.

Time frame: the first 72 hours post-operative, up to 4 days

ArmMeasureGroupValue (MEAN)Dispersion
Lidocaine Patch GroupVisual Analog Pain ScorePost-Op Day 13.5 score on a scaleStandard Deviation 2.3
Lidocaine Patch GroupVisual Analog Pain ScorePost-Op Day 25.2 score on a scaleStandard Deviation 2.6
Lidocaine Patch GroupVisual Analog Pain ScorePost-Op Day 35.2 score on a scaleStandard Deviation 2.1
Lidocaine Patch GroupVisual Analog Pain ScorePost-Op Day 45.7 score on a scaleStandard Deviation 1.9
Control GroupVisual Analog Pain ScorePost-Op Day 44.5 score on a scaleStandard Deviation 2.1
Control GroupVisual Analog Pain ScorePost-Op Day 14.1 score on a scaleStandard Deviation 2.5
Control GroupVisual Analog Pain ScorePost-Op Day 34.3 score on a scaleStandard Deviation 1.7
Control GroupVisual Analog Pain ScorePost-Op Day 25.2 score on a scaleStandard Deviation 2
Comparison: Post-Op Day 3p-value: 0.07t-test, 2 sided
Comparison: Post-Op Day 4p-value: 0.09t-test, 2 sided
Comparison: Post-Op Day 1p-value: 0.3t-test, 2 sided
Comparison: Post-Op Day 2p-value: 0.9t-test, 2 sided
Secondary

Narcotic Use

The total average milligrams of narcotic, or opioid, medication that a patient receives calculated in morphine equivalents

Time frame: the first 72 hours post-operative

ArmMeasureValue (MEAN)Dispersion
Lidocaine Patch GroupNarcotic Use51.3 mg morphine equivalentsStandard Deviation 53.6
Control GroupNarcotic Use29.7 mg morphine equivalentsStandard Deviation 35
p-value: 0.02t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026