Trial Outcomes & Findings for Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery? (NCT NCT03326999)
NCT ID: NCT03326999
Last Updated: 2020-09-30
Results Overview
Total amount of opioids consumed
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
up to 24 hours after surgery
Results posted on
2020-09-30
Participant Flow
Recruitment began in October with enrollment from December 2017 through December 2018.
Participant milestones
| Measure |
Investigational Arm
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
|
Control Arm
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?
Baseline characteristics by cohort
| Measure |
Bupivacaine Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
|
Saline Control Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
67.3 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.72 kg/m^2
STANDARD_DEVIATION 4.85 • n=5 Participants
|
28.65 kg/m^2
STANDARD_DEVIATION 5.05 • n=7 Participants
|
29.68 kg/m^2
STANDARD_DEVIATION 5.02 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 hours after surgeryTotal amount of opioids consumed
Outcome measures
| Measure |
Bupivacaine Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
|
Saline Control Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
|
|---|---|---|
|
Morphine Equivalence Consumption
|
12.6 MME
Standard Deviation 6.37
|
18.85 MME
Standard Deviation 7.74
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 hours after surgeryLikert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced
Outcome measures
| Measure |
Bupivacaine Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
|
Saline Control Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
|
|---|---|---|
|
Pain Score
1 hour
|
0.17 score on a scale
Standard Deviation 0.64
|
0.23 score on a scale
Standard Deviation 1.28
|
|
Pain Score
6 hours
|
2.27 score on a scale
Standard Deviation 2.82
|
2.77 score on a scale
Standard Deviation 2.71
|
|
Pain Score
12 hours
|
4.10 score on a scale
Standard Deviation 2.92
|
5.13 score on a scale
Standard Deviation 2.22
|
|
Pain Score
24 hours
|
6.10 score on a scale
Standard Deviation 2.66
|
7.00 score on a scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: up to 24 hours after surgeryYes or No responses when the subject is asked if the subject is feeling nauseous or has vomited
Outcome measures
| Measure |
Bupivacaine Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
|
Saline Control Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
|
|---|---|---|
|
Number of Participants With Nausea or Vomiting
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: on postoperative day 1 after surgeryThe length of time that it takes before the patient is first able to walk with assistance after surgery as assessed by a physical therapist.
Outcome measures
| Measure |
Bupivacaine Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
|
Saline Control Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
|
|---|---|---|
|
Time to Ambulation
|
8.98 hours
Standard Deviation 8.13
|
7.87 hours
Standard Deviation 8.49
|
SECONDARY outcome
Timeframe: up to post operative day 2 after surgeryTime before pain medication needed for breakthrough pain
Outcome measures
| Measure |
Bupivacaine Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
|
Saline Control Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
|
|---|---|---|
|
Time to Breakthrough Pain Medication
|
872.54 minutes
Standard Deviation 1044.07
|
510.13 minutes
Standard Deviation 420.69
|
SECONDARY outcome
Timeframe: 2 weeks after surgeryAnalgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.
Outcome measures
| Measure |
Bupivacaine Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine
|
Saline Control Arm
n=30 Participants
Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
|
|---|---|---|
|
Analgesia Satisfaction Score
|
9.24 score on a scale
Standard Deviation 0.93
|
8.59 score on a scale
Standard Deviation 2.08
|
Adverse Events
Investigational Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
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
Dr. Christina Jeng
Icahn School of Medicine at Mount Sinai
Phone: 212-241-6426
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place