Trial Outcomes & Findings for Perineural Local Anesthetic Administration With a Continuous Infusion Versus Automatic Intermittent Boluses (NCT NCT04458467)
NCT ID: NCT04458467
Last Updated: 2022-06-30
Results Overview
Rated 0-10 on numeric rating scale the average pain from the recovery room until the data collection call. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
postoperative day 1
Results posted on
2022-06-30
Participant Flow
One patient did not have a successful initial nerve block. Per protocol, the patient was not randomized and did not complete the study.
Participant milestones
| Measure |
Continuous Infusion
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Continuous Infusion
n=35 Participants
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
n=35 Participants
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 18 • n=35 Participants
|
48 years
STANDARD_DEVIATION 17 • n=35 Participants
|
50 years
STANDARD_DEVIATION 17 • n=70 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=35 Participants
|
19 Participants
n=35 Participants
|
41 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=35 Participants
|
16 Participants
n=35 Participants
|
29 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: postoperative day 1Rated 0-10 on numeric rating scale the average pain from the recovery room until the data collection call. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.
Outcome measures
| Measure |
Continuous Infusion
n=35 Participants
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
n=35 Participants
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
|---|---|---|
|
Average Pain Queried on First Postoperative Day
|
3 score on a scale
Interval 1.8 to 4.8
|
0.0 score on a scale
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 6 days postoperativelyNumber of hours from the time the pump is initiated until local anesthetic reservoir exhaustion
Outcome measures
| Measure |
Continuous Infusion
n=35 Participants
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
n=35 Participants
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
|---|---|---|
|
Duration of Infusion
|
74 Hours
Interval 57.0 to 80.0
|
119 Hours
Interval 109.0 to 125.0
|
SECONDARY outcome
Timeframe: Each of 6 days postoperativelyRated 0-10 on numeric rating scale. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.
Outcome measures
| Measure |
Continuous Infusion
n=35 Participants
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
n=35 Participants
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
|---|---|---|
|
Worst Pain
Day 1
|
5.3 score on a scale
Standard Deviation 3.4
|
3.3 score on a scale
Standard Deviation 3.7
|
|
Worst Pain
Day 2
|
6.9 score on a scale
Standard Deviation 2.4
|
4.6 score on a scale
Standard Deviation 3.2
|
|
Worst Pain
Day 3
|
4.9 score on a scale
Standard Deviation 2.7
|
3.6 score on a scale
Standard Deviation 3.0
|
|
Worst Pain
Day 4
|
6.1 score on a scale
Standard Deviation 2.6
|
3.0 score on a scale
Standard Deviation 3.1
|
|
Worst Pain
Day 5
|
5.1 score on a scale
Standard Deviation 2.8
|
3.3 score on a scale
Standard Deviation 3.2
|
|
Worst Pain
Day 6
|
4.3 score on a scale
Standard Deviation 3.2
|
3.7 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Each of 6 days postoperativelyRated 0-10 on numeric rating scale. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.
Outcome measures
| Measure |
Continuous Infusion
n=35 Participants
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
n=35 Participants
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
|---|---|---|
|
Average Pain
Day 1
|
3.0 score on a scale
Standard Deviation 2.4
|
1.6 score on a scale
Standard Deviation 2.0
|
|
Average Pain
Day 2
|
4.1 score on a scale
Standard Deviation 2.0
|
2.0 score on a scale
Standard Deviation 1.8
|
|
Average Pain
Day 3
|
3.0 score on a scale
Standard Deviation 2.0
|
1.6 score on a scale
Standard Deviation 1.6
|
|
Average Pain
Day 4
|
4.0 score on a scale
Standard Deviation 2.0
|
1.5 score on a scale
Standard Deviation 1.8
|
|
Average Pain
Day 5
|
3.1 score on a scale
Standard Deviation 1.7
|
1.7 score on a scale
Standard Deviation 1.8
|
|
Average Pain
Day 6
|
2.4 score on a scale
Standard Deviation 2.0
|
1.8 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Each of 6 days postoperativelyRated 0-10 on numeric rating scale. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.
Outcome measures
| Measure |
Continuous Infusion
n=35 Participants
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
n=35 Participants
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
|---|---|---|
|
Least Pain
Day 1
|
0.2 score on a scale
Standard Deviation 0.8
|
0.1 score on a scale
Standard Deviation 0.5
|
|
Least Pain
Day 2
|
1.1 score on a scale
Standard Deviation 1.5
|
0.7 score on a scale
Standard Deviation 1.2
|
|
Least Pain
Day 3
|
1.0 score on a scale
Standard Deviation 1.7
|
0.4 score on a scale
Standard Deviation 0.7
|
|
Least Pain
Day 4
|
1.8 score on a scale
Standard Deviation 1.8
|
0.5 score on a scale
Standard Deviation 1.1
|
|
Least Pain
Day 5
|
1.4 score on a scale
Standard Deviation 1.5
|
0.7 score on a scale
Standard Deviation 1.3
|
|
Least Pain
Day 6
|
1.2 score on a scale
Standard Deviation 1.5
|
0.8 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Each of 6 days postoperativelyRated 0-10 on numeric rating scale. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.
Outcome measures
| Measure |
Continuous Infusion
n=30 Participants
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
n=30 Participants
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
|---|---|---|
|
Current Pain
Day 1
|
2.8 score on a scale
Standard Deviation 2.8
|
1.7 score on a scale
Standard Deviation 2.5
|
|
Current Pain
Day 2
|
2.4 score on a scale
Standard Deviation 2.3
|
1.6 score on a scale
Standard Deviation 2.0
|
|
Current Pain
Day 3
|
1.9 score on a scale
Standard Deviation 2.0
|
1.2 score on a scale
Standard Deviation 1.4
|
|
Current Pain
Day 4
|
2.9 score on a scale
Standard Deviation 2.2
|
1.4 score on a scale
Standard Deviation 2.0
|
|
Current Pain
Day 5
|
2.0 score on a scale
Standard Deviation 1.9
|
1.9 score on a scale
Standard Deviation 2.3
|
|
Current Pain
Day 6
|
2.1 score on a scale
Standard Deviation 2.1
|
1.9 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Each of 6 days postoperativelyCumulative opioid consumption during the first 6 days postoperatively
Outcome measures
| Measure |
Continuous Infusion
n=35 Participants
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
n=35 Participants
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
|---|---|---|
|
Opioid Consumption
Day 1
|
1.4 Tablets
Standard Deviation 1.6
|
0.7 Tablets
Standard Deviation 1.2
|
|
Opioid Consumption
Day 2
|
2.0 Tablets
Standard Deviation 1.9
|
0.9 Tablets
Standard Deviation 1.3
|
|
Opioid Consumption
Day 3
|
1.7 Tablets
Standard Deviation 1.7
|
0.7 Tablets
Standard Deviation 1.4
|
|
Opioid Consumption
Day 4
|
2.3 Tablets
Standard Deviation 1.9
|
0.5 Tablets
Standard Deviation 1.3
|
|
Opioid Consumption
Day 5
|
1.3 Tablets
Standard Deviation 1.5
|
0.5 Tablets
Standard Deviation 1.2
|
|
Opioid Consumption
Day 6
|
0.8 Tablets
Standard Deviation 1.7
|
0.5 Tablets
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Each of 6 nights postoperativelyNumber of awakenings due to pain during the first 6 nights postoperatively
Outcome measures
| Measure |
Continuous Infusion
n=35 Participants
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
n=35 Participants
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
|---|---|---|
|
Sleep Disturbances Due to Pain
Day 1
|
1.0 Number of sleep disturbances
Standard Deviation 1.2
|
0.4 Number of sleep disturbances
Standard Deviation 0.7
|
|
Sleep Disturbances Due to Pain
Day 2
|
1.5 Number of sleep disturbances
Standard Deviation 1.6
|
0.5 Number of sleep disturbances
Standard Deviation 1.0
|
|
Sleep Disturbances Due to Pain
Day 3
|
0.8 Number of sleep disturbances
Standard Deviation 1.5
|
0.2 Number of sleep disturbances
Standard Deviation 0.5
|
|
Sleep Disturbances Due to Pain
Day 4
|
1.5 Number of sleep disturbances
Standard Deviation 1.6
|
0.2 Number of sleep disturbances
Standard Deviation 0.5
|
|
Sleep Disturbances Due to Pain
Day 5
|
1.1 Number of sleep disturbances
Standard Deviation 1.8
|
0.3 Number of sleep disturbances
Standard Deviation 0.8
|
|
Sleep Disturbances Due to Pain
Day 6
|
0.8 Number of sleep disturbances
Standard Deviation 1.5
|
0.4 Number of sleep disturbances
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Each of 6 days postoperativelyRate 0 = normal to 10 = insensate
Outcome measures
| Measure |
Continuous Infusion
n=35 Participants
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Continuous Infusion: A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
|
Automated Boluses
n=35 Participants
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Automated Intermittent Boluses: Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
|
|---|---|---|
|
Numbness in Foot and Ankle
Day 1
|
7.5 score on a scale
Standard Deviation 2.8
|
8.9 score on a scale
Standard Deviation 1.8
|
|
Numbness in Foot and Ankle
Day 2
|
5.1 score on a scale
Standard Deviation 3.4
|
7.9 score on a scale
Standard Deviation 1.8
|
|
Numbness in Foot and Ankle
Day 3
|
4.5 score on a scale
Standard Deviation 3.7
|
7.4 score on a scale
Standard Deviation 2.4
|
|
Numbness in Foot and Ankle
Day 4
|
0.6 score on a scale
Standard Deviation 1.8
|
7.2 score on a scale
Standard Deviation 2.8
|
|
Numbness in Foot and Ankle
Day 5
|
0 score on a scale
Standard Deviation 0
|
5.4 score on a scale
Standard Deviation 3.6
|
|
Numbness in Foot and Ankle
Day 6
|
0.0 score on a scale
Standard Deviation 0.0
|
1.5 score on a scale
Standard Deviation 3.2
|
Adverse Events
Continuous Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Automated Boluses
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