NCT00913003

Brief Summary

The aim of this study is to determine if perioperative systemic lidocaine administration will decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In addition, patients receiving systemic lidocaine will have a lower incidence of post-mastectomy pain syndrome. This study will have 2 groups. Participants will be randomized into one of each group. The first group will be administered the drug lidocaine prior to surgery and the second group Group B will be administered saline (salt water). This is a blinded study which means the participant will not know which group they have been assigned. The subjects participation will last 12 months (surveys post operatively).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started May 2009

Typical duration for phase_4 pain

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

February 4, 2015

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

June 2, 2009

Results QC Date

January 21, 2015

Last Update Submit

February 2, 2015

Conditions

Pain

Keywords

LidocaineMastectomyPain

Outcome Measures

Primary Outcomes (1)

  • 24 Hour Hydromorphone

    Total IV hydromorphone administered during surgery to 24 hours post surgery

    24 hour

Secondary Outcomes (2)

  • Number of Participants Experiencing Post Operative Nausea

    Immediate post operative to 48 hours

  • Number of Participants Experiencing Post Operative Ileus

    7 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Group B using saline as a placebo.

Drug: Placebo

Lidocaine

ACTIVE COMPARATOR

Group A lidocaine infusion and bolus.

Drug: Lidocaine

Interventions

LidocaineDRUG

Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)

Also known as: Group A
Lidocaine
PlaceboDRUG

Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug

Also known as: Group B
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-65 years
  • Gender: Female
  • ASA Physical Status I-III
  • Non-pregnant
  • Surgery: Unilateral total or segmental mastectomy
  • Language: English speaking
  • Consent: Obtained

You may not qualify if:

  • Age: Under 18 or over 65 years
  • ASA Physical Status \>III
  • Pregnancy
  • Language: Non-English speaking
  • Allergy to Lidocaine or amide local anesthetics
  • Contraindication to succinylcholine
  • History and/or EKG evidence of conduction defect
  • Renal failure (Creatinine \>1.7 mg/dL)
  • Patient expected to remain intubated after procedure
  • Chronic home opioid or steroid use
  • Opioid use within one week prior to procedure
  • Drug or alcohol abuse
  • Inability to use PCA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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: 9459225BACKGROUND

  • Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.

    PMID: 15763418BACKGROUND

  • 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: 17197840BACKGROUND

  • 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: 15041597BACKGROUND

  • Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. doi: 10.1038/sj.bjc.6602304.

    PMID: 15655557BACKGROUND

  • McCleane G. Intravenous lidocaine: an outdated or underutilized treatment for pain? J Palliat Med. 2007 Jun;10(3):798-805. doi: 10.1089/jpm.2006.0209.

    PMID: 17592992BACKGROUND

  • Owczuk R, Wujtewicz MA, Sawicka W, Piankowski A, Polak-Krzeminska A, Morzuch E, Wujtewicz M. The effect of intravenous lidocaine on QT changes during tracheal intubation. Anaesthesia. 2008 Sep;63(9):924-31. doi: 10.1111/j.1365-2044.2008.05525.x. Epub 2008 Jun 10.

    PMID: 18547294BACKGROUND

  • Violet JA, Dearling JL, Green AJ, Begent RH, Pedley RB. Fractionated 131I anti-CEA radioimmunotherapy: effects on xenograft tumour growth and haematological toxicity in mice. Br J Cancer. 2008 Aug 19;99(4):632-8. doi: 10.1038/sj.bjc.6604511.

    PMID: 18682714BACKGROUND

  • Cheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. doi: 10.1002/jso.20782.

    PMID: 17457830BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

This study was terminated early because the PI left the institution.

Results Point of Contact

Title
Paul Fitzgerald
Organization
Northwestern University
p-fitzgerald2@northwestern.edu
312-695- 1064

Study Officials

  • Christian Altman, M.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 3, 2009

Study Start

May 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 4, 2015

Results First Posted

February 4, 2015

Record last verified: 2015-02