Trial Outcomes & Findings for Arthroscopic Anterior Cruciate Ligament Reconstruction: A Comparison of Three Catheter Placement Positions (NCT NCT00178178)
NCT ID: NCT00178178
Last Updated: 2015-09-11
Results Overview
Pain over the first three days post-operatively. This will be identified by the use of the Postoperative Patient Diary. This document records patient's subjective evaluations of pain, comfort, ability to sleep, activity administered daily on the day of surgery and each morning and each evening before the patient retires for 3 postoperative days. All pain medications taken during the 3 days of the postoperative evaluation will be recorded on the Postoperative Patient Diary.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
3 day
Results posted on
2015-09-11
Participant Flow
Participant milestones
| Measure |
Intraarticulary Only
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
Patellar Tendon Harvest Site Only
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
Patellar Tendon Harvest Site and Intraarticular
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
Placebo
Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Arthroscopic Anterior Cruciate Ligament Reconstruction: A Comparison of Three Catheter Placement Positions
Baseline characteristics by cohort
| Measure |
Drug: Intraarticularly Only
n=24 Participants
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
Drug: Patellar Tendon Harvest Site Only
n=24 Participants
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
Drug: Patellar Tendon Harvest Site and Intraarticular
n=24 Participants
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
Placebo Comparator
n=24 Participants
Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
31 Participants
n=390 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
20 Participants
n=157 Participants
|
65 Participants
n=390 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
27 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
20 Participants
n=157 Participants
|
69 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
24 Participants
n=157 Participants
|
96 Participants
n=390 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
4 Participants
n=390 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
21 Participants
n=157 Participants
|
90 Participants
n=390 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
24 participants
n=107 Participants
|
24 participants
n=206 Participants
|
24 participants
n=157 Participants
|
96 participants
n=390 Participants
|
PRIMARY outcome
Timeframe: 3 dayPain over the first three days post-operatively. This will be identified by the use of the Postoperative Patient Diary. This document records patient's subjective evaluations of pain, comfort, ability to sleep, activity administered daily on the day of surgery and each morning and each evening before the patient retires for 3 postoperative days. All pain medications taken during the 3 days of the postoperative evaluation will be recorded on the Postoperative Patient Diary.
Outcome measures
| Measure |
Intraarticulary Only
n=24 Participants
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
Patellar Tendon Harvest Site Only
n=24 Participants
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
Patellar Tendon Harvest Site and Intraarticular
n=24 Participants
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
Placebo
n=24 Participants
Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter
Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days.
|
|---|---|---|---|---|
|
Pain
|
24 participants that experienced pain
|
24 participants that experienced pain
|
24 participants that experienced pain
|
24 participants that experienced pain
|
Adverse Events
Intraartciularly Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patellar Tendon Harvest Site Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patellar Tendon Harvest Site and Intraarticular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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