Intravenous Lidocaine & Quality of Recovery After Cesarean Delivery

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Pregnancy

Clinical Trial Details

NCT number	NCT02257346
Study type	Interventional
Source	Northwestern University
Contact
Status	Withdrawn
Phase	N/A
Start date	November 1, 2014
Completion date	February 15, 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms