Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery

NCT02257346 | Withdrawn

• 1 other identifier: Lidocaine-RCT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Pregnancy; Lidocaine; Quality; Recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (2)

• Opioid consumption

  1 day

• Skin-to-skin time

  1 day

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine

Normal Saline

PLACEBO COMPARATOR

Intravenous normal saline infusion

Drug: Normal Saline

Interventions

Lidocaine DRUG

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

Also known as: Xylocaine

Lidocaine

Normal Saline DRUG

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

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists Class II
• English speaking
• Scheduled Cesarean delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

NorthwesternUniversity

Chicago, Illinois, 60611, United States

Location

Related Publications (10)

• 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.

  PMID: 20110561 BACKGROUND

• 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.

  PMID: 15041597 BACKGROUND

• 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.

  PMID: 9459225 BACKGROUND

• 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.

  PMID: 17197840 BACKGROUND

• 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.

  PMID: 18844267 BACKGROUND

• Gill TM, Feinstein AR. A critical appraisal of the quality of quality-of-life measurements. JAMA. 1994 Aug 24-31;272(8):619-26.

  PMID: 7726894 BACKGROUND

• Guyatt GH, Cook DJ. Health status, quality of life, and the individual. JAMA. 1994 Aug 24-31;272(8):630-1. No abstract available.

  PMID: 8057520 BACKGROUND

• 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.

  PMID: 12651647 BACKGROUND

• 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.

  PMID: 9895071 BACKGROUND

• 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.

  PMID: 10740540 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jason R Farrer, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: October 6, 2014
• Study Start: November 1, 2014
• Primary Completion: February 15, 2015
• Study Completion: February 15, 2015
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)