Trial Outcomes & Findings for Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures (NCT NCT05714631)
NCT ID: NCT05714631
Last Updated: 2026-07-08
Results Overview
Oral Morphine Equivalents Calculated based on opioids used between enrollment in the study until the time of discharge
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
From date of enrollment until the date of discharge, assessed up to 1 week in a typical hospital stay
Results posted on
2026-07-08
Participant Flow
Participant milestones
| Measure |
Standard of Care Group
Patients in the standard of care will not be receiving any lidocaine or placebo patches. The aim of this group is to control for the placebo effect.
|
Placebo Group
Placebo Patch: Transdermal placebo patch
|
Intervention Group
4% Lidocaine Patch: Transdermal patch
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lidocaine Patches in Elderly Patients With Traumatic Rib Fractures
Baseline characteristics by cohort
| Measure |
Standard of Care Group
n=2 Participants
Patients in the standard of care will not be receiving any lidocaine or placebo patches. The aim of this group is to control for the placebo effect.
|
Placebo Group
n=2 Participants
Placebo Patch: Transdermal placebo patch
|
Intervention Group
n=1 Participants
4% Lidocaine Patch: Transdermal patch
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=9 Participants
|
67.5 years
n=27 Participants
|
80 years
n=267 Participants
|
70.8 years
n=265 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: From date of enrollment until the date of discharge, assessed up to 1 week in a typical hospital stayOral Morphine Equivalents Calculated based on opioids used between enrollment in the study until the time of discharge
Outcome measures
| Measure |
Intervention Group
n=1 Participants
4% Lidocaine Patch: Transdermal patch
|
Standard of Care Group
n=2 Participants
Patients in the standard of care will not be receiving any lidocaine or placebo patches. The aim of this group is to control for the placebo effect.
|
Placebo Group
n=2 Participants
Placebo Patch: Transdermal placebo patch
|
|---|---|---|---|
|
Oral Morphine Equivalent
|
11 mg
Interval 11.0 to 11.0
|
138.5 mg
Interval 47.0 to 230.0
|
43 mg
Interval 11.0 to 75.0
|
SECONDARY outcome
Timeframe: Daily median score from post enrollment until dischargePatient will report numerical pain score (0 (no pain) -10 (worst pain imaginable)) as part of standard nursing assessments. A median pain score will be calculated from all the values collected on each hospital day. Median scores will be reported for each day from the date of enrollment until the date of discharge.
Outcome measures
| Measure |
Intervention Group
n=1 Participants
4% Lidocaine Patch: Transdermal patch
|
Standard of Care Group
n=2 Participants
Patients in the standard of care will not be receiving any lidocaine or placebo patches. The aim of this group is to control for the placebo effect.
|
Placebo Group
n=2 Participants
Placebo Patch: Transdermal placebo patch
|
|---|---|---|---|
|
Pain Scores
|
4 units on a scale
Interval 4.0 to 4.0
|
5.5 units on a scale
Interval 4.0 to 7.0
|
2.5 units on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Total from Hospital discharge until 30 days post dischargeTotal oral morphine equivalents in mg of opioids prescribed to each patient from the time of discharge until 30 days post discharge
Outcome measures
| Measure |
Intervention Group
n=1 Participants
4% Lidocaine Patch: Transdermal patch
|
Standard of Care Group
n=2 Participants
Patients in the standard of care will not be receiving any lidocaine or placebo patches. The aim of this group is to control for the placebo effect.
|
Placebo Group
n=2 Participants
Placebo Patch: Transdermal placebo patch
|
|---|---|---|---|
|
Post Discharge Opioid Prescription
|
15 mg
Interval 15.0 to 15.0
|
37.5 mg
Interval 30.0 to 45.0
|
22.5 mg
Interval 0.0 to 45.0
|
Adverse Events
Standard of Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place