Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery

Northwestern University

Status: Withdrawn

Conditions: Pregnancy

Treatments: Drug: Lidocaine; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02257346

Lidocaine-RCT

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 2 patient groups, including a placebo group

Lidocaine

Active Comparator group

Description:

Intravenous lidocaine 1.5 mg/Kg bolus dose and 2mg/Kg/hr infusion

Treatment:

Drug: Lidocaine

Normal Saline

Placebo Comparator group

Description:

Intravenous normal saline infusion

Treatment:

Drug: Normal Saline