Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery
NCT ID: NCT02257346
Last Updated: 2022-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-11-01
2015-02-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lidocaine
Intravenous lidocaine 1.5 mg/Kg bolus dose and 2mg/Kg/hr infusion
Lidocaine
Lidocaine infusion will be administered immediately after delivery of the fetus and continue through 1 hour into recovery period.
Normal Saline
Intravenous normal saline infusion
Normal Saline
Normal Saline will be administered as a placebo immediately after delivery of the fetus and continue through 1 hour into recovery period
Interventions
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Lidocaine
Lidocaine infusion will be administered immediately after delivery of the fetus and continue through 1 hour into recovery period.
Normal Saline
Normal Saline will be administered as a placebo immediately after delivery of the fetus and continue through 1 hour into recovery period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English speaking
* Scheduled Cesarean delivery
Exclusion Criteria
* Chronic opioid use
* Greater than 2 prior cesarean deliveries
* Prior myomectomy
* Prior classical cesarean incision
* BMI greater than 40
* History of cardiac disease
18 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Jason Farrer
Clinical Instructor
Principal Investigators
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Jason R Farrer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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NorthwesternUniversity
Chicago, Illinois, United States
Countries
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References
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Bramson L, Lee JW, Moore E, Montgomery S, Neish C, Bahjri K, Melcher CL. Effect of early skin-to-skin mother--infant contact during the first 3 hours following birth on exclusive breastfeeding during the maternity hospital stay. J Hum Lact. 2010 May;26(2):130-7. doi: 10.1177/0890334409355779. Epub 2010 Jan 28.
Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.
Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.
Gill TM, Feinstein AR. A critical appraisal of the quality of quality-of-life measurements. JAMA. 1994 Aug 24-31;272(8):619-26.
Guyatt GH, Cook DJ. Health status, quality of life, and the individual. JAMA. 1994 Aug 24-31;272(8):630-1. No abstract available.
Watcha MF, Issioui T, Klein KW, White PF. Costs and effectiveness of rofecoxib, celecoxib, and acetaminophen for preventing pain after ambulatory otolaryngologic surgery. Anesth Analg. 2003 Apr;96(4):987-994. doi: 10.1213/01.ANE.0000053255.93270.31.
Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.
Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
Other Identifiers
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Lidocaine-RCT
Identifier Type: -
Identifier Source: org_study_id
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