Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery

This study has been terminated.
(PI terminated employment with the University)
Sponsor:
Information provided by (Responsible Party):
Christian Altman, Northwestern University
ClinicalTrials.gov Identifier:
NCT00913003
First received: June 2, 2009
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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).


Condition Intervention Phase
Pain
Drug: Lidocaine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Post mastectomy pain syndrome [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post operative nausea and vomiting [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Post operative ileus [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: May 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Group B using saline as a placebo.
Drug: Placebo
Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug
Other Name: Group B
Active Comparator: Lidocaine
Group A lidocaine infusion and bolus.
Drug: Lidocaine
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)
Other Name: Group A

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913003

Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Christian Altman, M.D. Northwestern University
  More Information

Publications:

Responsible Party: Christian Altman, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT00913003     History of Changes
Other Study ID Numbers: STU0008753
Study First Received: June 2, 2009
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Lidocaine
Mastectomy
Pain

Additional relevant MeSH terms:
Analgesics
Lidocaine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014