The OBstetric Lidocaine Patch (OBLido) Trial

Pain, Postoperative Clinical Trial

— OBLido  

Official title:

Transdermal Lidocaine Patch for Post-Cesarean Pain Control for Women With Obesity: a Single-blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810235
• Other study ID #: Meriter IRB 2018-015
• Secondary ID: A532860SMPH/OBST
• Status: Completed
• Phase: Phase 4
• Start date: February 15, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: October 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be a single-center, single blind, randomized controlled trial. The study will be conducted at UnityPoint-Health Meriter Hospital under investigators from the University of Wisconsin-Madison. Obstetric patients with prepregnancy obesity undergoing a Cesarean delivery at UnityPoint-Health Meriter will be eligible.

Description:

The purpose of this study is to determine whether transdermal lidocaine administered at the time of Cesarean delivery and for 12 hours postoperatively will reduce the total dose of opioids received. Our hypothesis is that a lidocaine patch will reduce the total dose of opioids received in the immediate 24 hours post-delivery. Secondary outcomes will include patient self-reported pain scores, patient-reported incidence of side effects, such as pruritis, development of objective complications, such as serious skin reactions (examples are acute generalized exanthematous pustolosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis), hypersensitivity, nausea, and nervousness. Other outcomes collected will include length of stay, time to first rescue analgesic medication, total dose of opioids in 48 hours, use of supplemental oxygen during hospitalization, total dose of opioids during hospitalization, breastfeeding rates, both exclusive and in combination with formula use, amount of opioid prescribed at discharge and whether refills were requested or administered, rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen scores. Neonatal outcomes such as five-minute Apgar scores and development of adverse outcomes will also be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 30, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Maternal age greater than or equal to 18

• Prepregnancy body mass index greater than or equal to 30 kg/m2 or =35 kg/m2 at delivery if no prepregnancy/ early pregnancy weight available

• Singleton or multifetal pregnancy

• Able to receive neuraxial analgesia

• Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery with adequate time to consider and consent to the study

• Gestational age greater or equal to 32 weeks

Exclusion Criteria:

• Known hypersensitivity to lidocaine or colloid patch (defined as a history of a reaction or allergy to lidocaine (injectable, intravenous, or transdermal) or hydrocolloid patch reported by patient or documented in the medical record) or patient report

• Contraindication to regional analgesia

• Positive urine drug screen at admission to the hospital, if ordered for clinical purposes.

• Current opioid use or opioid use disorder per patient report or documented in the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery)

• Chronic opioid use or opioid use disorder, either patient reported or documented in the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery), defined as opioid use on most days for >3 months

• Planned Cesarean hysterectomy (excluded due to anticipated blood loss and alternative pain control measures, possible prolonged intubation)

• Planned vertical midline incision

• Presence of renal dysfunction precluding the use of NSAIDs

• Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy

• Coagulopathy

• Planned discharge from the hospital less than 24 hours postpartum

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Transdermal Lidocaine Patch
Transdermal Lidocaine Patch
• Transdermal Hydrocolloid Placebo Patch
hydrocolloid placebo patches

Locations

Country	Name	City	State
United States	UnityPoint Health-Meriter Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Opioid-related Side Effects	Patient-reported opioid-related side effects include pruritis, constipation, nausea, and mental clouding.; Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)	up to 6 weeks postpartum
Other	Number of Participants With Complications of Lidocaine Use	Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.; Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)	up to 6 weeks postpartum
Other	Length of Hospital Stay	Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge	up to 120 hours
Other	Time to First Rescue Opioid Analgesic Medication	Measured in minutes from arrival in the post-anesthesia care unit (PACU) until the first as needed opioid dose is administered. This will be recorded in minutes from the time of the surgery completion (surgery end time) until the first opioid analgesic medication is administered. Data in table is noted in hours.	up to 24 hours
Other	Total Dose of Opioids Used in the First 48 Hours Post-operatively	All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received in 48 hours following surgery calculated as oral morphine equivalents	up to 48 hours
Other	Total Dose of Opioids During the Whole Hospitalization.	All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received during the hospitalization (following surgery) calculated as oral morphine equivalents.	up to 120 hours
Other	Number of Participants With Postoperative Complications	Includes urinary tract infections, thromboembolic events, pneumonia, postpartum blood transfusions, falls, myocardial infarctions.; These events will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)	up to 120 hours
Other	Number of Opioid Pills Prescribed at Discharge	The number of opioid pills prescribed at discharge	up to 72 hours
Other	Neonatal Outcomes: Gestational Age at Delivery	Gestational age at delivery will be recorded as weeks and days of gestation	up to 24 hours
Other	Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge	Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge	up to 72 hours
Primary	Total Dose of Opioids Received in the First 24 Hours Following Cesarean	The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.	up to 24 hours
Secondary	Post-operative Pain Score at 24 Hours Post-operatively	The post-operative pain score at 24 hours post-operatively will be measured using the numeric rating scale (NRS), wherein subjects rate pain on a 0-10 scale (10 meaning the most pain and 0 meaning no pain). The median NRS score at 24 hours will be compared between the two groups.	up to 24 hours