Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery

Study Overview
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Brief Summary
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When given intravenously, the local anesthetic lidocaine has been shown to decrease the amount of pain medication patients require when recovering from several types of surgeries. Cesarean delivery is a very common surgery in the United States, effecting more than 1 million women each year. The investigators hypothesize that lidocaine, given during and immediately after a patient undergoes a cesarean section, will help improve a mother's overall recovery experience, as well as positively influence bonding with her new baby.

Detailed Description
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Pain after Cesarean delivery is a common occurrence on the labor and delivery unit. The increased use of neuraxial anesthesia has allowed the administration of neuraxial opioids to help with postoperative pain control. Many patients, however, still require IV and oral opioids in the post anesthesia recovery unit (PACU), and on the postpartum nursing floor. Post Cesarean delivery pain not only has the usual adverse effects common to all postoperative pain (i.e. increased risk for deep vein thrombosis, pulmonary embolism, coronary ischemia, pneumonia, poor wound healing, and psychological dysfunction) but also has the potential to adversely affect mother-baby bonding, time spent in skin-to-skin contact and success of initiating effective breastfeeding. Systemic administration of lidocaine has been shown to decrease opioid consumption, improve recovery of bowel function and promote a better recovery after inpatient procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and anti-inflammatory properties. It also has an excellent safety profile when given by a low-dose infusion. Assessing a patient's quality of recovery has become an important outcome in several studies. The patient's capacity to return to her normal activities and effectively care for her newborn is one of the most important signs of a successful surgical procedure, and it has significant economic, sociological and psychological implications. Quality of recovery -40(QoR-40) is a validated 40-item instrument to assess the quality of post-operative recovery (10). Myles et al. have concluded that the QoR-40 would be a useful outcome measure to assess the impact on changes in health care delivery, but anesthesia studies underutilize this instrument. This study will evaluate the effect of perioperative systemic lidocaine in the postoperative quality of recovery of patients undergoing Cesarean delivery.

Official Title
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The Effect of Perioperative Systemic Lidocaine on Quality of Recovery After Cesarean Delivery

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists Class II English speaking Scheduled Cesarean delivery Exclusion Criteria: Allergy to local anesthetics Chronic opioid use Greater than 2 prior cesarean deliveries Prior myomectomy Prior classical cesarean incision BMI greater than 40 History of cardiac disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Intravenous lidocaine 1.5 mg/Kg bolus dose and 2mg/Kg/hr infusion | Drug: Lidocaine<br>* Lidocaine infusion will be administered immediately after delivery of the fetus and continue through 1 hour into recovery period.<br>* Other names: Xylocaine;|
| Placebo Comparator: Normal Saline<br>Intravenous normal saline infusion | Drug: Normal Saline<br>* Normal Saline will be administered as a placebo immediately after delivery of the fetus and continue through 1 hour into recovery period<br>* Other names: 0.9% Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery 40 on the day after surgery | The quality of recovery 40 (QoR-40) is a validated questionnaire used to assess several variables that effect a patient's post-operative experience. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Total opioid consumption for the first 24 hours after delivery | 1 day | 
| Skin-to-skin time | Percentage of time a patient spends in skin to skin contact with their newborn in the first 24 hours. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Lidocaine, Quality, Recovery