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

February 2, 2015 updated by: Christian Altman, Northwestern University

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited up to 21 days prior to the day of surgery. The consent form will be reviewed with the patient, and the patient will be allowed to take a copy home. If the patient does not have an EKG within the past 6 weeks in her medical record, an EKG will be obtained at the time of recruitment. At the time of recruitment, the patient will be randomized using a computer-generated code. Group A will receive lidocaine during surgery, and Group B will receive saline (placebo) during surgery.The study drug will be prepared by the investigator(s). The anesthesiologist and research nurse will be blinded. If necessary in the event of an emergency, these individuals may be unblinded.

Group A (Lidocaine):

Induction: 1.5 mg/kg IV (IBW) bolus, administered prior to Propofol. The maximum loading dose administered will not exceed 150 mg IV Infusion: 33.3 mcg/kg/min IV (IBW), initiated before surgical incision.Discontinue infusion 1 hour after skin closure complete.No other local anesthetics administered intra-operatively

Group B (Saline):

Induction: IV bolus, administered prior to Propofol Infusion: Initiate before surgical incision (rate calculated as if for lidocaine infusion). Discontinue infusion 1 hour after skin closure complete No local anesthetics administered intra-operatively. Baseline thermal quantitative sensory testing (QST) scores will be obtained pre-operatively using TSA-II Neuro Sensory Analyzer (Medoc Advanced Medical Systems, Durham, NC).

Baseline Modified Quality of Recovery (MQoR-40) Survey will be obtained on the morning of surgery.

Preoperative anxiety, depression, and pain characterization will be measured within 24 hours of the time of surgery using a validated questionnaire (Hospital Anxiety and Depression Scale). If the questionnaire responses indicate the patient is experiencing depressive symptoms, the patient will be notified of the results and instructed to follow up with her primary care physician.

Intraoperatively, patients will receive a standardized anesthetic (management protocol attached).

Two blood samples for lidocaine levels will be obtained on subjects. The first lidocaine blood sample will be collected after the lidocaine/placebo bolus in the operating room. The second lidocaine blood sample will be obtained when the lidocaine/placebo infusion has been discontinued (one hour after skin closure). A total of 5 mLs of blood will be obtained.

Patients will be examined daily by a research nurse while admitted to the hospital. Daily pain scores will be noted, as will complications related to the perioperative period. If the subject is discharged within 24 hours the research nurse will call by phone to ask the subject about pain 0-10 and type and amount of pain relievers used since discharge.MQoR-40 will be administered on the day of discharge. It will be repeated at 6 weeks, 6 months, and 12 months after surgery. Patients will complete the Mastectomy Patient Follow-Up, Modified LANNS Pain Scale, and McGill Pain questionnaires at 6 months and 12 months after surgery for detection of Post-Mastectomy Pain Syndrome (PMPS).

The definition of PMPS will be: The presence of a dull, burning,and aching sensation in the anterior chest, arm, and axilla exacerbated by movement of the shoulder girdle.

Appendix 1-Anesthetic Management Protocol Appendix 2-HADS Appendix 3-MQoR-40 Appendix 4-Modified LANNS and McGill Appendix 5-Follow-Up Questionnaire

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Group A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 Hour Hydromorphone
Time Frame: 24 hour
Total IV hydromorphone administered during surgery to 24 hours post surgery
24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Post Operative Nausea
Time Frame: Immediate post operative to 48 hours
Nausea at any time during the post operative period for 48 hours
Immediate post operative to 48 hours
Number of Participants Experiencing Post Operative Ileus
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Christian Altman, M.D., Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU0008753

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe