An interventional study of Lidocaine and Normal Saline in Pregnancy, sponsored by Northwestern University. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-09.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
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.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous lidocaine 1.5 mg/Kg bolus dose and 2mg/Kg/hr infusion
Drug: Lidocaine
Intravenous normal saline infusion
Drug: Normal Saline
Lidocaine infusion will be administered immediately after delivery of the fetus and continue through 1 hour into recovery period.
Also known as: Xylocaine
Normal Saline will be administered as a placebo immediately after delivery of the fetus and continue through 1 hour into recovery period
Also known as: 0.9% Saline
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.
Time frame: 1 day
Opioid consumption
Total opioid consumption for the first 24 hours after delivery
Time frame: 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.
Time frame: 1 day
Plan to share: No
This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Northwestern University