Trial Outcomes & Findings for Anterior Cruciate Ligament Pain Study (NCT NCT02604550)
NCT ID: NCT02604550
Last Updated: 2017-05-31
Results Overview
Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.
COMPLETED
PHASE4
115 participants
Post-surgery (day of surgery to 6 days post-surgery)
2017-05-31
Participant Flow
Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center in Atlanta, Georgia were prospectively randomized to receive either a femoral nerve block (FNB) or an adductor canal block (ACB). Participants were enrolled between December 2015 and April 2016.
Participant milestones
| Measure |
Femoral Nerve Block
Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
59
|
|
Overall Study
COMPLETED
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
25
|
26
|
Reasons for withdrawal
| Measure |
Femoral Nerve Block
Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Incomplete data using paper journal
|
18
|
19
|
Baseline Characteristics
Anterior Cruciate Ligament Pain Study
Baseline characteristics by cohort
| Measure |
Femoral Nerve Block
n=56 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=59 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
37 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 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
|
13 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
59 participants
n=7 Participants
|
115 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-surgery (day of surgery to 6 days post-surgery)Population: This analysis includes participants who completed the study and used a smartphone application to record pain level for 6 days post-surgery.
Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.
Outcome measures
| Measure |
Femoral Nerve Block
n=31 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=33 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Pain Score
Recovery room discharge
|
4.1 units on a scale
Standard Deviation 1.8
|
4.0 units on a scale
Standard Deviation 2.8
|
|
Pain Score
Day of surgery, evening
|
3.9 units on a scale
Standard Deviation 2.2
|
5.1 units on a scale
Standard Deviation 2.9
|
|
Pain Score
Post-surgery Day 1 - Morning
|
5.7 units on a scale
Standard Deviation 2.6
|
5.7 units on a scale
Standard Deviation 2.4
|
|
Pain Score
Post-surgery Day 1 - Afternoon
|
5.1 units on a scale
Standard Deviation 2.3
|
5.0 units on a scale
Standard Deviation 1.8
|
|
Pain Score
Post-surgery Day 1 - Evening
|
5.5 units on a scale
Standard Deviation 2.3
|
6.0 units on a scale
Standard Deviation 2.1
|
|
Pain Score
Post-surgery Day 2 - Morning
|
5.4 units on a scale
Standard Deviation 2.3
|
5.3 units on a scale
Standard Deviation 2.3
|
|
Pain Score
Post-surgery Day 2 - Afternoon
|
4.5 units on a scale
Standard Deviation 1.9
|
4.6 units on a scale
Standard Deviation 1.8
|
|
Pain Score
Post-surgery Day 2 - Evening
|
4.3 units on a scale
Standard Deviation 2.0
|
4.5 units on a scale
Standard Deviation 2.1
|
|
Pain Score
Post-surgery Day 3 - Morning
|
4.2 units on a scale
Standard Deviation 2.0
|
4.0 units on a scale
Standard Deviation 3.1
|
|
Pain Score
Post-surgery Day 3 - Afternoon
|
3.8 units on a scale
Standard Deviation 1.9
|
3.4 units on a scale
Standard Deviation 2.5
|
|
Pain Score
Post-surgery Day 3 - Evening
|
4.0 units on a scale
Standard Deviation 2.1
|
3.7 units on a scale
Standard Deviation 2.3
|
|
Pain Score
Post-surgery Day 4 - Morning
|
3.5 units on a scale
Standard Deviation 2.2
|
3.0 units on a scale
Standard Deviation 2.2
|
|
Pain Score
Post-surgery Day 4 - Afternoon
|
3.2 units on a scale
Standard Deviation 2.1
|
2.7 units on a scale
Standard Deviation 2.0
|
|
Pain Score
Post-surgery Day 4 - Evening
|
4.0 units on a scale
Standard Deviation 2.4
|
3.3 units on a scale
Standard Deviation 2.4
|
|
Pain Score
Post-surgery Day 5 - Morning
|
3.7 units on a scale
Standard Deviation 2.2
|
3.1 units on a scale
Standard Deviation 2.1
|
|
Pain Score
Post-surgery Day 5 - Afternoon
|
3.6 units on a scale
Standard Deviation 2.1
|
3.3 units on a scale
Standard Deviation 2.2
|
|
Pain Score
Post-surgery Day 5 - Evening
|
3.4 units on a scale
Standard Deviation 2.3
|
3.3 units on a scale
Standard Deviation 2.4
|
|
Pain Score
Post-surgery Day 6 - Morning
|
3.7 units on a scale
Standard Deviation 2.2
|
3.1 units on a scale
Standard Deviation 2.2
|
|
Pain Score
Post-surgery Day 6 - Evening
|
2.7 units on a scale
Standard Deviation 1.6
|
2.8 units on a scale
Standard Deviation 2.2
|
|
Pain Score
Post-surgery Day 6 - Afternoon
|
3.2 units on a scale
Standard Deviation 1.6
|
3.2 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Post surgery, Day 0 to Day 6Population: This analysis includes participants who completed the study and used a smartphone application to record the number of Percocet tablets taken for 6 days post-surgery.
Participants recorded the total number of Percocet 7.5/325 (acetaminophen and oxycodone) tablets they took every day, in order to assess post-surgical use of opioids between the study arms,
Outcome measures
| Measure |
Femoral Nerve Block
n=31 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=33 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Number of Percocet Tablets Consumed
Day of surgery (Day 0)
|
2.0 count of tablets
Standard Deviation 1.2
|
2.4 count of tablets
Standard Deviation 1.7
|
|
Number of Percocet Tablets Consumed
Post-surgery Day 1
|
4.6 count of tablets
Standard Deviation 2.5
|
4.7 count of tablets
Standard Deviation 2.9
|
|
Number of Percocet Tablets Consumed
Post-surgery Day 2
|
3.7 count of tablets
Standard Deviation 2.6
|
3.6 count of tablets
Standard Deviation 2.6
|
|
Number of Percocet Tablets Consumed
Post-surgery Day 5
|
0.6 count of tablets
Standard Deviation 1.4
|
1.4 count of tablets
Standard Deviation 1.5
|
|
Number of Percocet Tablets Consumed
Post-surgery Day 6
|
0.3 count of tablets
Standard Deviation 0.7
|
0.4 count of tablets
Standard Deviation 0.7
|
|
Number of Percocet Tablets Consumed
Post-surgery Day 3
|
2.3 count of tablets
Standard Deviation 1.9
|
2.2 count of tablets
Standard Deviation 2.2
|
|
Number of Percocet Tablets Consumed
Post-surgery Day 4
|
1.1 count of tablets
Standard Deviation 1.3
|
1.2 count of tablets
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: First Postoperative Night (up to 12 hours)Population: This analysis includes participants who completed the study and used a smartphone application to record their number of hours of sleep during the night following their surgery.
The total hours of sleep first postoperative night, between 0 to 12 hours.
Outcome measures
| Measure |
Femoral Nerve Block
n=31 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=33 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Total Hours of Sleep
|
6.3 hours
Standard Deviation 2.0
|
5.8 hours
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Post-Surgery (up to 6 days)Population: This analysis includes participants completing the study who used a smartphone application for 6 days post-operatively to record every time they experienced nausea.
Total occurrences of patient-reported nausea post-surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=31 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=33 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Patient-Reported Nausea
|
3 occurrence of nausea
|
2 occurrence of nausea
|
SECONDARY outcome
Timeframe: Post-Surgery (up to 6 days)Population: This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced vomiting.
Total occurrences of patient-reported vomiting post-surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=31 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=33 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Patient-Reported Vomiting
|
1 occurrence of vomiting
|
1 occurrence of vomiting
|
SECONDARY outcome
Timeframe: Post-Surgery (up to 6 days)Population: This analysis includes participants completing the study and who used a smartphone application for 6 days post-operatively to record every time they experienced constipation.
Total occurrences of patient-reported constipation post-surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=31 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=33 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Patient-Reported Constipation
|
2 occurrence of constipation
|
1 occurrence of constipation
|
SECONDARY outcome
Timeframe: Post-Surgery (up to 6 days)Population: This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced feelings of sedation.
Total occurrences of patient-reported feelings of sedation post-surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=31 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=33 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Patient-Reported Sedation
|
0 occurrence of sedation
|
0 occurrence of sedation
|
SECONDARY outcome
Timeframe: Post-Surgery (up to 6 days)Population: This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced itching.
Total occurrences of patient-reported itching post-surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=31 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=33 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Patient-Reported Itching
|
2 occurrence of itching
|
1 occurrence of itching
|
SECONDARY outcome
Timeframe: Post-Surgery (up to 6 days)Population: This analysis includes participants who completed the study and used a smartphone application to record when they were able to perform a straight leg raise following surgery.
The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=31 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=33 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Time to Straight Less Raise
|
31.7 hours
Standard Deviation 26.1
|
16.4 hours
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 2 Weeks Post-SurgeryPopulation: This analysis includes participants who completed the study and used a smartphone application to record study outcome measures following surgery.
Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery.
Outcome measures
| Measure |
Femoral Nerve Block
n=31 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
|
Adductor Canal Block
n=33 Participants
Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
|
|---|---|---|
|
Percent of Patients Rating Their Satisfaction as "Excellent" or "Good"
|
39 percentage of participants
|
64 percentage of participants
|
Adverse Events
Femoral Nerve Block
Adductor Canal Block
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