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Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02257346
Enrollment
0
Registered
2014-10-06
Start date
2014-11-01
Completion date
2015-02-15
Last updated
2022-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Pregnancy, Lidocaine, Quality, Recovery

Brief 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.

Detailed 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.

Interventions

DRUGLidocaine

Lidocaine infusion will be administered immediately after delivery of the fetus and continue through 1 hour into recovery period.

DRUGNormal Saline

Normal Saline will be administered as a placebo immediately after delivery of the fetus and continue through 1 hour into recovery period

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery 40 on the day after surgery1 dayThe quality of recovery 40 (QoR-40) is a validated questionnaire used to assess several variables that effect a patient's post-operative experience.

Secondary

MeasureTime frameDescription
Opioid consumption1 dayTotal opioid consumption for the first 24 hours after delivery
Skin-to-skin time1 dayPercentage of time a patient spends in skin to skin contact with their newborn in the first 24 hours.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026