Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery
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 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|
- 24 Hour Hydromorphone [ Time Frame: 24 hour ] [ Designated as safety issue: No ]Total IV hydromorphone administered during surgery to 24 hours post surgery
- Number of Participants Experiencing Post Operative Nausea [ Time Frame: Immediate post operative to 48 hours ] [ Designated as safety issue: No ]Nausea at any time during the post operative period for 48 hours
- Number of Participants Experiencing Post Operative Ileus [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Group B using saline as a 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.
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00913003
|Principal Investigator:||Christian Altman, M.D.||Northwestern University|