Trial Outcomes & Findings for Initial Local Anesthetic Dose With Continuous Interscalene Analgesia (NCT NCT00672100)
NCT ID: NCT00672100
Last Updated: 2017-03-07
Results Overview
Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Discharge, 24 h, 48h, 12 weeks
Results posted on
2017-03-07
Participant Flow
Patients were identified from the surgical schedule. Subjects consented using the most current IRB-approved consent form. Informed consent were administered in the pre-operative suites prior to receiving any treatment. Recruitment started after approval was obtained from the IRB. Recruitment period was Jan 2009 to Dec 2009.
Subjects were screened per protocol, those that met all inclusion criteria and did not meet any exclusion criteria were randomized per protocol.
Participant milestones
| Measure |
Ropivacaine 5 mL
Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 10 mL
Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 20 mL
Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
PACU (Within 8 Hours)
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Initial Local Anesthetic Dose With Continuous Interscalene Analgesia
Baseline characteristics by cohort
| Measure |
Ropivacaine 5 mL
n=12 Participants
Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 10 mL
n=12 Participants
Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 20 mL
n=12 Participants
Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Total
n=36 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
36 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Discharge, 24 h, 48h, 12 weeksPain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)
Outcome measures
| Measure |
Ropivacaine 5 mL
n=12 Participants
Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 10 mL
n=12 Participants
Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 20 mL
n=12 Participants
Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
|---|---|---|---|
|
Pain Measurements Via Numeric Pain Rating Scales (NRS)
NRS at 48 hours post discharge
|
2.67 units on a scale
Interval 1.08 to 4.25
|
2.08 units on a scale
Interval 0.66 to 3.5
|
2.15 units on a scale
Interval 0.92 to 3.38
|
|
Pain Measurements Via Numeric Pain Rating Scales (NRS)
NRS at Discharge
|
2.67 units on a scale
Interval 0.61 to 4.71
|
1.58 units on a scale
Interval -0.18 to 3.35
|
0.62 units on a scale
Interval -0.26 to 1.49
|
|
Pain Measurements Via Numeric Pain Rating Scales (NRS)
NRS at 24 hours post discharge
|
3.67 units on a scale
Interval 2.03 to 5.3
|
3.33 units on a scale
Interval 1.57 to 5.1
|
2.54 units on a scale
Interval 1.09 to 3.99
|
|
Pain Measurements Via Numeric Pain Rating Scales (NRS)
NRS at 12 weeks post discharge (n=11, 12, 12)
|
1.5 units on a scale
Interval 0.5 to 2.5
|
2.42 units on a scale
Interval 0.55 to 4.28
|
1.15 units on a scale
Interval 0.42 to 1.89
|
PRIMARY outcome
Timeframe: Baseline, Post anesthesia care unit (PACU) - within 8 hoursDiaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit.
Outcome measures
| Measure |
Ropivacaine 5 mL
n=12 Participants
Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 10 mL
n=12 Participants
Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 20 mL
n=12 Participants
Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
|---|---|---|---|
|
Change in Diaphragmatic Displacement From Baseline to Post-surgery
% change in diaphragm displacement ipsilateral
|
66 percent change
Interval 43.0 to 88.0
|
60 percent change
Interval 21.0 to 98.0
|
65 percent change
Interval 45.0 to 86.0
|
|
Change in Diaphragmatic Displacement From Baseline to Post-surgery
% change in diaphragm displacement contralateral
|
-28 percent change
Interval -45.0 to -10.0
|
-56 percent change
Interval -139.0 to 26.0
|
-39 percent change
Interval -114.0 to 36.0
|
SECONDARY outcome
Timeframe: at 24 and 48 hours after discharge from the hospitalParticipants were asked to rate the helpfulness of their infusion: 1. extremely harmful 2. harmful 3. neutral 4. not harmful, but not helpful 5. helpful 6. extremely helpful
Outcome measures
| Measure |
Ropivacaine 5 mL
n=12 Participants
Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 10 mL
n=12 Participants
Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 20 mL
n=12 Participants
Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
|---|---|---|---|
|
Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful"
Percentage of participants at 24 hours
|
83 percentage of participants
|
83 percentage of participants
|
92 percentage of participants
|
|
Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful"
Percentage of participants at 48 hours
|
83 percentage of participants
|
75 percentage of participants
|
85 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksAt baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed.
Outcome measures
| Measure |
Ropivacaine 5 mL
n=36 Participants
Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 10 mL
Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
Ropivacaine 20 mL
Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
|
|---|---|---|---|
|
Functional Outcome - Simple Shoulder Test (SST)
SST at Baseline (n=36)
|
6.3 units on a scale
Interval 5.1 to 7.5
|
—
|
—
|
|
Functional Outcome - Simple Shoulder Test (SST)
SST at 12 weeks (n=35)
|
8.2 units on a scale
Interval 7.3 to 9.2
|
—
|
—
|
Adverse Events
Ropivacaine 5 mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine 10 mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine 20 mL
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