Trial Outcomes & Findings for A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery (NCT NCT01300377)
NCT ID: NCT01300377
Last Updated: 2026-09-01
Results Overview
Comparing the patients that received post operative morphine (or equivalents) in the Bupivacaine/Lidocaine versus the Lidocaine alone.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
350 participants
Primary outcome timeframe
1 day
Results posted on
2026-09-01
Participant Flow
Participant milestones
| Measure |
Bupivacaine / Lidocaine
Lidocaine/Bupivacaine mixture - 5 cubic centimeter (cc) 1% Lidocaine solution mixed with 5 cc 0.25% Bupivacaine solution administered locally to the surgical site at time of the surgical procedure. Administered once only.
Bupivacaine / Lidocaine: 5cc 1% Lidocaine solution mixed with 5 cc 0.25% Bupivacaine solution administered locally to the surgical site at time of the surgical procedure. Administered once only.
|
Lidocaine
Lidocaine - 10 cubic centimeter (cc) 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
Lidocaine: 10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
173
|
|
Overall Study
Screen Failed
|
0
|
0
|
|
Overall Study
COMPLETED
|
177
|
173
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery
Baseline characteristics by cohort
| Measure |
Bupivacaine / Lidocaine
n=177 Participants
Lidocaine/Bupivacaine mixture - 5 cubic centimeter (cc) 1% Lidocaine solution mixed with 5 cc 0.25% Bupivacaine solution administered locally to the surgical site at time of the surgical procedure. Administered once only.
Bupivacaine / Lidocaine: 5cc 1% Lidocaine solution mixed with 5 cc 0.25% Bupivacaine solution administered locally to the surgical site at time of the surgical procedure. Administered once only.
|
Lidocaine
n=173 Participants
Lidocaine - 10 cubic centimeter (cc) 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
Lidocaine: 10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=14 Participants
|
27 Participants
n=36 Participants
|
54 Participants
n=324 Participants
|
|
Race (NIH/OMB)
White
|
149 Participants
n=14 Participants
|
145 Participants
n=36 Participants
|
294 Participants
n=324 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=14 Participants
|
46 Participants
n=36 Participants
|
94 Participants
n=324 Participants
|
|
Age, Categorical
>=65 years
|
129 Participants
n=14 Participants
|
127 Participants
n=36 Participants
|
256 Participants
n=324 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=14 Participants
|
63 Participants
n=36 Participants
|
128 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=14 Participants
|
110 Participants
n=36 Participants
|
222 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=14 Participants
|
9 Participants
n=36 Participants
|
18 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=14 Participants
|
164 Participants
n=36 Participants
|
332 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
|
Region of Enrollment
United States
|
177 participants
n=14 Participants
|
173 participants
n=36 Participants
|
350 participants
n=324 Participants
|
|
Type of Surgery: ICD
|
177 Participants
n=14 Participants
|
173 Participants
n=36 Participants
|
350 Participants
n=324 Participants
|
PRIMARY outcome
Timeframe: 1 dayComparing the patients that received post operative morphine (or equivalents) in the Bupivacaine/Lidocaine versus the Lidocaine alone.
Outcome measures
| Measure |
Bupivacaine / Lidocaine
n=177 Participants
Lidocaine/Bupivacaine mixture - 5cc 1% Lidocaine solution mixed with 5 cc 0.25% Bupivacaine solution administered locally to the surgical site at time of the surgical procedure. Administered once only.
Bupivacaine / Lidocaine: 5cc 1% Lidocaine solution mixed with 5 cc 0.25% Bupivacaine solution administered locally to the surgical site at time of the surgical procedure. Administered once only.
|
Lidocaine
n=173 Participants
Lidocaine - 10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
Lidocaine: 10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
|
|---|---|---|
|
Patients With Post-Operative Narcotic Use
|
109 Participants
|
103 Participants
|
Adverse Events
Bupivacaine / Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine
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
Dr. Elisa Priest
Baylor Scott and White Resarch Institute
Phone: 214-679-9412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place