AzTrials
AzTrials

PregnancyNCT02257346

Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery

A study testing Lidocaine and Normal Saline in people with Pregnancy, run by Northwestern University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy
What is being tested?
Lidocaine and Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Nov 2014to 15 Feb 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NorthwesternUniversity

    Chicago, Illinois, 60611

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Pregnancy
Being tested
Lidocaine, Normal Saline
Keywords
Pregnancy, Lidocaine, Quality, Recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    Also called Xylocaine

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

  • Normal SalineDrug

    Also called 0.9% Saline

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

Study groups in NCT02257346
Study groupRoleWhat they receive
LidocaineActive comparatorIntravenous lidocaine 1.5 mg/Kg bolus dose and 2mg/Kg/hr infusion
Receives: Drug: Lidocaine
Normal SalinePlacebo comparatorIntravenous normal saline infusion
Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day

Secondary outcomes (2)

  1. Opioid consumption

    Total opioid consumption for the first 24 hours after delivery

    Measured: 1 day

  2. Skin-to-skin time

    Percentage of time a patient spends in skin to skin contact with their newborn in the first 24 hours.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2014 (estimated)
  2. Study start1 Nov 2014
  3. Primary completion15 Feb 2015
  4. Study completion15 Feb 2015

Why it stopped: PI terminated study with no subjects enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02257346
Sponsor's protocol ID
Lidocaine-RCT
Status last verified
Jun 2022
First submitted
16 Jul 2014
Last updated
9 Jun 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20110561

  • 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.

    PubMed 15041597

  • 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.

    PubMed 9459225

  • 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.

    PubMed 17197840

  • 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.

    PubMed 18844267

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

    PubMed 7726894

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

    PubMed 8057520

  • 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.

    PubMed 12651647

  • 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.

    PubMed 9895071

  • 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.

    PubMed 10740540

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine and Normal Saline in people with Pregnancy, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery 40 on the day after surgery (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02257346, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in