Trial Outcomes & Findings for The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty (NCT NCT00620828)
NCT ID: NCT00620828
Last Updated: 2015-06-03
Results Overview
Participants were asked to rate their pain on a scale of 0 to 10 at all time intervals up to 24 hours post-injection. Scores were organized into the following categories: 3 or less (mild pain), 4 to 6 (moderate pain), 7 or higher (severe pain).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
67 participants
Primary outcome timeframe
Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection
Results posted on
2015-06-03
Participant Flow
12 of the 79 subjects enrolled were screening failures, thus total number of subjects completing the study = 67. One patient had staged bilateral TKA so there are 66 total patients, but 67 injections given.
12 of the 79 subjects enrolled were screening failures
Participant milestones
| Measure |
Control Group
Subjects receive intra-op saline injection per protocol
|
Block Group
Subjects receive intra-op Ropivicaine 0.5% injection per protocol
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
35
|
|
Overall Study
Number of Subjects Enrolled = 67
|
32
|
35
|
|
Overall Study
COMPLETED
|
32
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Control Group
n=32 Participants
Subjects receive intra-op saline injection per protocol
|
Block Group
n=35 Participants
Subjects receive intra-op Ropivicaine 0.5% injection per protocol
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 2 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 2 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
35 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Lean Body Weight
|
59.9 kg
STANDARD_DEVIATION 12.4 • n=5 Participants
|
62.9 kg
STANDARD_DEVIATION 11.1 • n=7 Participants
|
61.4 kg
STANDARD_DEVIATION 11.75 • n=5 Participants
|
PRIMARY outcome
Timeframe: Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injectionPopulation: per protocol
Participants were asked to rate their pain on a scale of 0 to 10 at all time intervals up to 24 hours post-injection. Scores were organized into the following categories: 3 or less (mild pain), 4 to 6 (moderate pain), 7 or higher (severe pain).
Outcome measures
| Measure |
Block Group
n=35 Participants
Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
|
Control Group
n=32 Participants
Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
|
|---|---|---|
|
Numeric Pain Score
PACU
|
0.67 units on a scale
Standard Deviation 1.4 • Interval 0.0 to 0.0
|
1.6 units on a scale
Standard Deviation 2.8 • Interval 0.0 to 0.0
|
|
Numeric Pain Score
4 hours
|
2.5 units on a scale
Standard Deviation 2.7
|
3.6 units on a scale
Standard Deviation 2.8
|
|
Numeric Pain Score
8 hours
|
3.8 units on a scale
Standard Deviation 2.6
|
4.9 units on a scale
Standard Deviation 2.8
|
|
Numeric Pain Score
12 hours
|
3.2 units on a scale
Standard Deviation 1.9
|
3.9 units on a scale
Standard Deviation 2.6
|
|
Numeric Pain Score
24 hours
|
3.9 units on a scale
Standard Deviation 2.7
|
4.9 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 4 hours to 24 hours post-opThe PCA total dose at the 4-hour, 8-hour, 12-hour and 24-hour post-operative time points.
Outcome measures
| Measure |
Block Group
n=35 Participants
Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
|
Control Group
n=32 Participants
Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
|
|---|---|---|
|
Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption
4 hours
|
22.4 micrograms
Standard Deviation 38.1
|
43.7 micrograms
Standard Deviation 71.9
|
|
Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption
8 hours
|
95.6 micrograms
Standard Deviation 103.3
|
126.6 micrograms
Standard Deviation 106.4
|
|
Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption
12 hours
|
173.4 micrograms
Standard Deviation 175.4
|
205.6 micrograms
Standard Deviation 177.5
|
|
Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption
24 hours
|
418.5 micrograms
Standard Deviation 424.4
|
292.2 micrograms
Standard Deviation 402.1
|
SECONDARY outcome
Timeframe: 24 hours post-opAmbulation distance walked by participants 24-hours post-operatively
Outcome measures
| Measure |
Block Group
n=35 Participants
Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
|
Control Group
n=32 Participants
Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
|
|---|---|---|
|
Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance
|
38.4 Feet
Standard Deviation 45.0
|
26.4 Feet
Standard Deviation 27.7
|
SECONDARY outcome
Timeframe: 24 hours post-opKnee extension and knee flexion measured at 24-hours post-operatively for patient cohort
Outcome measures
| Measure |
Block Group
n=35 Participants
Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
|
Control Group
n=32 Participants
Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
|
|---|---|---|
|
Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion
Knee extension
|
7.8 degrees
Standard Deviation 4.5
|
7.0 degrees
Standard Deviation 4.8
|
|
Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion
Knee flexion
|
71.5 degrees
Standard Deviation 13.9
|
69.6 degrees
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 4 hours, 8 hours, 12 hours and 24 hours post-opStraight Leg Raise (SLR): number of people that can perform a SLR at designated intervals
Outcome measures
| Measure |
Block Group
n=35 Participants
Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
|
Control Group
n=32 Participants
Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
|
|---|---|---|
|
Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise
SLR 4 hrs
|
4 participants
|
5 participants
|
|
Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise
SLR 8 hrs
|
13 participants
|
5 participants
|
|
Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise
SLR 12 hrs
|
12 participants
|
5 participants
|
|
Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise
SLR 24 hrs
|
13 participants
|
6 participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Block 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