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Trial record 19 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

Symptom Management After Breast Cancer 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: NCT00686127
Recruitment Status : Completed
First Posted : May 29, 2008
Results First Posted : May 1, 2014
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Neuropathic Pain
Postmastectomy Pain
Interventions Drug: Lidoderm patch
Drug: Placebo patch
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lidocaine Patch Placebo Patch
Hide Arm/Group Description Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day. Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
Period Title: Overall Study
Started 14 7
Completed 0 [1] 1
Not Completed 14 6
Reason Not Completed
Withdrawal by Subject             14             6
[1]
Patients withdrew from the study because they did not like wearing the patch.
Arm/Group Title Lidocaine Patch Placebo Patch Total
Hide Arm/Group Description Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day. Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day. Total of all reporting groups
Overall Number of Baseline Participants 14 7 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 7 participants 21 participants
51.2  (10.3) 46.1  (13.5) 49.5  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 7 participants 21 participants
Female
14
 100.0%
7
 100.0%
21
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 7 participants 21 participants
White 9 2 11
Black 3 0 3
Asian/Pacific Islander 1 3 4
Hispanic or Mixed Ethnic Background 1 2 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 7 participants 21 participants
14 7 21
Average pain intensity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 14 participants 7 participants 21 participants
5.3  (2.3) 4.2  (1.1) 4.8  (1.9)
[1]
Measure Description: Patients scored their pain intensity in the breast and/or ipsilateral arm at enrollment using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10)
Worst pain intensity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 14 participants 7 participants 21 participants
7.8  (1.5) 6.4  (4.8) 7.1  (3.3)
[1]
Measure Description: Patients scored their pain intensity in the breast and/or ipsilateral arm at enrollment using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10)
1.Primary Outcome
Title Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks
Hide Description Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study attempted to evaluate changes in average pain intensity following breast cancer surgery. However, since none of the patients in the lidocaine group completed the 12 week trial, the outcomes of this study cannot be evaluated.
Arm/Group Title Lidocaine Patch Placebo Patch
Hide Arm/Group Description:
Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: units on a scale
4
2.Secondary Outcome
Title Pain Interference With Function
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lidocaine Patch Placebo Patch
Hide Arm/Group Description Lidocaine patch One patch is changed every twenty-four hours Placebo patch: Patch is changed every 24 hours
All-Cause Mortality
Lidocaine Patch Placebo Patch
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lidocaine Patch Placebo Patch
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lidocaine Patch Placebo Patch
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christine Miaskowski, PI
Organization: University of California, San Francisco
Phone: 415-476-9407
EMail: chris.miaskowski@nursing.ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00686127     History of Changes
Other Study ID Numbers: Breast Pain
CA107091
First Submitted: May 27, 2008
First Posted: May 29, 2008
Results First Submitted: February 14, 2014
Results First Posted: May 1, 2014
Last Update Posted: June 28, 2018