Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00913003|
Recruitment Status : Terminated (PI terminated employment with the University)
First Posted : June 3, 2009
Results First Posted : February 4, 2015
Last Update Posted : February 4, 2015
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 or disease||Intervention/treatment||Phase|
|Pain||Drug: Lidocaine Drug: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
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
- 24 Hour Hydromorphone [ Time Frame: 24 hour ]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 ]Nausea at any time during the post operative period for 48 hours
- Number of Participants Experiencing Post Operative Ileus [ Time Frame: 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913003
|Principal Investigator:||Christian Altman, M.D.||Northwestern University|