Trial Outcomes & Findings for Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy (NCT NCT01242644)
NCT ID: NCT01242644
Last Updated: 2020-11-27
Results Overview
Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
8 hours post surgery
Results posted on
2020-11-27
Participant Flow
Participant milestones
| Measure |
Pain Pump , Injectable Medication
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
|
Saline Pain Pump , Injectable Medication
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
|
Injectable Medication Only
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
15
|
|
Overall Study
COMPLETED
|
16
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
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 |
Pain Pump , Injectable Medication
n=16 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
|
Saline Pain Pump , Injectable Medication
n=17 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
|
Injectable Medication Only
n=15 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 0.9 • n=16 Participants
|
51 years
STANDARD_DEVIATION 0.9 • n=17 Participants
|
49.9 years
STANDARD_DEVIATION 0.9 • n=15 Participants
|
51 years
STANDARD_DEVIATION 0.9 • n=48 Participants
|
|
Sex/Gender, Customized
Female
|
6 participants
n=16 Participants
|
10 participants
n=17 Participants
|
8 participants
n=15 Participants
|
24 participants
n=48 Participants
|
|
Sex/Gender, Customized
Male
|
10 participants
n=16 Participants
|
7 participants
n=17 Participants
|
7 participants
n=15 Participants
|
24 participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
17 participants
n=17 Participants
|
15 participants
n=15 Participants
|
48 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: 8 hours post surgeryVisual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Outcome measures
| Measure |
Pain Pump , Injectable Medication
n=16 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
|
Saline Pain Pump , Injectable Medication
n=17 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
|
Injectable Medication Only
n=15 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
|
|---|---|---|---|
|
Pain Score 8 Hours Post-operativley
|
2.5 units on a scale
Standard Deviation 0.3282
|
1.8 units on a scale
Standard Deviation 0.3282
|
1.06 units on a scale
Standard Deviation 0.3282
|
PRIMARY outcome
Timeframe: 24 hours post surgeryVisual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Outcome measures
| Measure |
Pain Pump , Injectable Medication
n=16 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
|
Saline Pain Pump , Injectable Medication
n=17 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
|
Injectable Medication Only
n=15 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
|
|---|---|---|---|
|
Pain Scale
|
1.75 units on a scale
Standard Deviation 0.16
|
3.23 units on a scale
Standard Deviation 0.16
|
3.06 units on a scale
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: 48 hours post-surgeryVisual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Outcome measures
| Measure |
Pain Pump , Injectable Medication
n=16 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
|
Saline Pain Pump , Injectable Medication
n=17 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
|
Injectable Medication Only
n=15 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
|
|---|---|---|---|
|
Pain Scale
|
1.81 units on a scale
Standard Deviation 0.14
|
3.17 units on a scale
Standard Deviation 0.14
|
2.26 units on a scale
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: 72 hours post surgeryVisual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Outcome measures
| Measure |
Pain Pump , Injectable Medication
n=16 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
|
Saline Pain Pump , Injectable Medication
n=17 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
|
Injectable Medication Only
n=15 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
|
|---|---|---|---|
|
Pain Scale
|
3.3 units on a scale
Standard Deviation 0.46
|
4.05 units on a scale
Standard Deviation 0.46
|
3.13 units on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: In recovery roomPill count
Outcome measures
| Measure |
Pain Pump , Injectable Medication
n=16 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
|
Saline Pain Pump , Injectable Medication
n=17 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
|
Injectable Medication Only
n=15 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
|
|---|---|---|---|
|
Number of Narcotic Pills and Morphine Sulfate Used
|
2.2 Pills
Standard Deviation 0.61
|
1.8 Pills
Standard Deviation 0.61
|
1.3 Pills
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Post surgery day 1Pill Count
Outcome measures
| Measure |
Pain Pump , Injectable Medication
n=16 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
|
Saline Pain Pump , Injectable Medication
n=17 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
|
Injectable Medication Only
n=15 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
|
|---|---|---|---|
|
Number of Narcotic Pills and Morphine Sulfate Used
|
3.41 Number of pills
Standard Deviation 0.87
|
3.8 Number of pills
Standard Deviation 0.87
|
3.8 Number of pills
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Post surgery day 2Outcome measures
| Measure |
Pain Pump , Injectable Medication
n=16 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
|
Saline Pain Pump , Injectable Medication
n=17 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
|
Injectable Medication Only
n=15 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
|
|---|---|---|---|
|
Number of Narcotic Pills and Morphine Sulfate Used
|
1.1 Number of pills
Standard Deviation 0.08
|
1.5 Number of pills
Standard Deviation 0.08
|
0.8 Number of pills
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Post surgery day 3Outcome measures
| Measure |
Pain Pump , Injectable Medication
n=16 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
|
Saline Pain Pump , Injectable Medication
n=17 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
|
Injectable Medication Only
n=15 Participants
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
|
|---|---|---|---|
|
Number of Narcotic Pills and Morphine Sulfate Used
|
2.1 number of pills
Standard Deviation 0.16
|
2.7 number of pills
Standard Deviation 0.16
|
1.7 number of pills
Standard Deviation 0.16
|
Adverse Events
Pain Pump , Injectable Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Pain Pump , Injectable Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Injectable Medication Only
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
Office of Research Compliance
University of South Alabama
Phone: 251-460-7573
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place