Anterior Cruciate Ligament Reconstruction
Conditions
Brief summary
The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.
Detailed description
This trial is a prospective, randomized, surgeon-blinded, two-armed trial to investigate the safety and efficacy of femoral nerve blocks versus adductor canal blocks for participants undergoing outpatient anterior cruciate ligament (ACL) reconstruction surgery. The objective of this study is to compare the pain control benefit of two different types of nerve blocks. Ropivacaine, which is FDA-approved for use in both femoral nerve blocks as well as adductor canal blocks, will be utilized. The study will be comparing the efficacy between FDA approved treatments.
Interventions
DRUGRopivacaine 0.5%
Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.
DRUGPercocet 7.5/325
Percocet 7.5/325 will taken as needed up to every four hours.
DRUGNaprosyn 500 mg
Naprosyn 500 mg will be taken twice daily.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center * Patients willing and able to provide written informed consent * Parents willing and able to provide written informed consent for minors
Exclusion criteria
* Patients who are pregnant or lactating * Patients with liver dysfunction or renal failure * Patients with a known allergy to ropivacaine * Patients with a local infection * Patients who take chronic pain medications * Patients with an opioid tolerance * Patients with known coagulopathy or bleeding risk. * Patients who are getting neuraxial anesthesia for surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Post-surgery (day of surgery to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Hours of Sleep | First Postoperative Night (up to 12 hours) | The total hours of sleep first postoperative night, between 0 to 12 hours. |
| Patient-Reported Nausea | Post-Surgery (up to 6 days) | Total occurrences of patient-reported nausea post-surgery. |
| Patient-Reported Vomiting | Post-Surgery (up to 6 days) | Total occurrences of patient-reported vomiting post-surgery. |
| Patient-Reported Constipation | Post-Surgery (up to 6 days) | Total occurrences of patient-reported constipation post-surgery. |
| Number of Percocet Tablets Consumed | Post surgery, Day 0 to Day 6 | 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, |
| Patient-Reported Itching | Post-Surgery (up to 6 days) | Total occurrences of patient-reported itching post-surgery. |
| Time to Straight Less Raise | Post-Surgery (up to 6 days) | The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery. |
| Percent of Patients Rating Their Satisfaction as Excellent or Good | 2 Weeks Post-Surgery | Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery. |
| Patient-Reported Sedation | Post-Surgery (up to 6 days) | Total occurrences of patient-reported feelings of sedation post-surgery. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Femoral Nerve Block Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve. | 56 |
| Adductor Canal Block Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal | 59 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete data using paper journal | 18 | 19 |
| Overall Study | Lost to Follow-up | 7 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Femoral Nerve Block | Adductor Canal Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 17 Participants | 31 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 42 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 35 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 24 Participants | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 13 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 24 Participants | 37 Participants |
| Race (NIH/OMB) White | 26 Participants | 21 Participants | 47 Participants |
| Region of Enrollment United States | 56 participants | 59 participants | 115 participants |
| Sex: Female, Male Female | 31 Participants | 33 Participants | 64 Participants |
| Sex: Female, Male Male | 25 Participants | 26 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 59 |
| other Total, other adverse events | 0 / 56 | 0 / 59 |
| serious Total, serious adverse events | 0 / 56 | 0 / 59 |
Outcome results
Primary
Pain Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Femoral Nerve Block | Pain Score | Recovery room discharge | 4.1 units on a scale | Standard Deviation 1.8 |
| Femoral Nerve Block | Pain Score | Day of surgery, evening | 3.9 units on a scale | Standard Deviation 2.2 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 1 - Morning | 5.7 units on a scale | Standard Deviation 2.6 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 1 - Afternoon | 5.1 units on a scale | Standard Deviation 2.3 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 1 - Evening | 5.5 units on a scale | Standard Deviation 2.3 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 2 - Morning | 5.4 units on a scale | Standard Deviation 2.3 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 2 - Afternoon | 4.5 units on a scale | Standard Deviation 1.9 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 2 - Evening | 4.3 units on a scale | Standard Deviation 2 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 3 - Morning | 4.2 units on a scale | Standard Deviation 2 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 3 - Afternoon | 3.8 units on a scale | Standard Deviation 1.9 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 3 - Evening | 4.0 units on a scale | Standard Deviation 2.1 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 4 - Morning | 3.5 units on a scale | Standard Deviation 2.2 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 4 - Afternoon | 3.2 units on a scale | Standard Deviation 2.1 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 4 - Evening | 4.0 units on a scale | Standard Deviation 2.4 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 5 - Morning | 3.7 units on a scale | Standard Deviation 2.2 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 5 - Afternoon | 3.6 units on a scale | Standard Deviation 2.1 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 5 - Evening | 3.4 units on a scale | Standard Deviation 2.3 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 6 - Morning | 3.7 units on a scale | Standard Deviation 2.2 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 6 - Afternoon | 3.2 units on a scale | Standard Deviation 1.6 |
| Femoral Nerve Block | Pain Score | Post-surgery Day 6 - Evening | 2.7 units on a scale | Standard Deviation 1.6 |
| Adductor Canal Block | Pain Score | Post-surgery Day 6 - Morning | 3.1 units on a scale | Standard Deviation 2.2 |
| Adductor Canal Block | Pain Score | Recovery room discharge | 4.0 units on a scale | Standard Deviation 2.8 |
| Adductor Canal Block | Pain Score | Post-surgery Day 3 - Evening | 3.7 units on a scale | Standard Deviation 2.3 |
| Adductor Canal Block | Pain Score | Day of surgery, evening | 5.1 units on a scale | Standard Deviation 2.9 |
| Adductor Canal Block | Pain Score | Post-surgery Day 5 - Afternoon | 3.3 units on a scale | Standard Deviation 2.2 |
| Adductor Canal Block | Pain Score | Post-surgery Day 1 - Morning | 5.7 units on a scale | Standard Deviation 2.4 |
| Adductor Canal Block | Pain Score | Post-surgery Day 4 - Morning | 3.0 units on a scale | Standard Deviation 2.2 |
| Adductor Canal Block | Pain Score | Post-surgery Day 1 - Afternoon | 5.0 units on a scale | Standard Deviation 1.8 |
| Adductor Canal Block | Pain Score | Post-surgery Day 6 - Evening | 2.8 units on a scale | Standard Deviation 2.2 |
| Adductor Canal Block | Pain Score | Post-surgery Day 1 - Evening | 6.0 units on a scale | Standard Deviation 2.1 |
| Adductor Canal Block | Pain Score | Post-surgery Day 4 - Afternoon | 2.7 units on a scale | Standard Deviation 2 |
| Adductor Canal Block | Pain Score | Post-surgery Day 2 - Morning | 5.3 units on a scale | Standard Deviation 2.3 |
| Adductor Canal Block | Pain Score | Post-surgery Day 5 - Evening | 3.3 units on a scale | Standard Deviation 2.4 |
| Adductor Canal Block | Pain Score | Post-surgery Day 2 - Afternoon | 4.6 units on a scale | Standard Deviation 1.8 |
| Adductor Canal Block | Pain Score | Post-surgery Day 4 - Evening | 3.3 units on a scale | Standard Deviation 2.4 |
| Adductor Canal Block | Pain Score | Post-surgery Day 2 - Evening | 4.5 units on a scale | Standard Deviation 2.1 |
| Adductor Canal Block | Pain Score | Post-surgery Day 6 - Afternoon | 3.2 units on a scale | Standard Deviation 2 |
| Adductor Canal Block | Pain Score | Post-surgery Day 3 - Morning | 4.0 units on a scale | Standard Deviation 3.1 |
| Adductor Canal Block | Pain Score | Post-surgery Day 5 - Morning | 3.1 units on a scale | Standard Deviation 2.1 |
| Adductor Canal Block | Pain Score | Post-surgery Day 3 - Afternoon | 3.4 units on a scale | Standard Deviation 2.5 |
Secondary
Number of Percocet Tablets Consumed
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,
Time frame: Post surgery, Day 0 to Day 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Femoral Nerve Block | Number of Percocet Tablets Consumed | Post-surgery Day 2 | 3.7 count of tablets | Standard Deviation 2.6 |
| Femoral Nerve Block | Number of Percocet Tablets Consumed | Post-surgery Day 4 | 1.1 count of tablets | Standard Deviation 1.3 |
| Femoral Nerve Block | Number of Percocet Tablets Consumed | Post-surgery Day 1 | 4.6 count of tablets | Standard Deviation 2.5 |
| Femoral Nerve Block | Number of Percocet Tablets Consumed | Post-surgery Day 5 | 0.6 count of tablets | Standard Deviation 1.4 |
| Femoral Nerve Block | Number of Percocet Tablets Consumed | Post-surgery Day 3 | 2.3 count of tablets | Standard Deviation 1.9 |
| Femoral Nerve Block | Number of Percocet Tablets Consumed | Post-surgery Day 6 | 0.3 count of tablets | Standard Deviation 0.7 |
| Femoral Nerve Block | Number of Percocet Tablets Consumed | Day of surgery (Day 0) | 2.0 count of tablets | Standard Deviation 1.2 |
| Adductor Canal Block | Number of Percocet Tablets Consumed | Post-surgery Day 6 | 0.4 count of tablets | Standard Deviation 0.7 |
| Adductor Canal Block | Number of Percocet Tablets Consumed | Day of surgery (Day 0) | 2.4 count of tablets | Standard Deviation 1.7 |
| Adductor Canal Block | Number of Percocet Tablets Consumed | Post-surgery Day 1 | 4.7 count of tablets | Standard Deviation 2.9 |
| Adductor Canal Block | Number of Percocet Tablets Consumed | Post-surgery Day 2 | 3.6 count of tablets | Standard Deviation 2.6 |
| Adductor Canal Block | Number of Percocet Tablets Consumed | Post-surgery Day 3 | 2.2 count of tablets | Standard Deviation 2.2 |
| Adductor Canal Block | Number of Percocet Tablets Consumed | Post-surgery Day 4 | 1.2 count of tablets | Standard Deviation 2.1 |
| Adductor Canal Block | Number of Percocet Tablets Consumed | Post-surgery Day 5 | 1.4 count of tablets | Standard Deviation 1.5 |
Secondary
Patient-Reported Constipation
Total occurrences of patient-reported constipation post-surgery.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Femoral Nerve Block | Patient-Reported Constipation | 2 occurrence of constipation |
| Adductor Canal Block | Patient-Reported Constipation | 1 occurrence of constipation |
Secondary
Patient-Reported Itching
Total occurrences of patient-reported itching post-surgery.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Femoral Nerve Block | Patient-Reported Itching | 2 occurrence of itching |
| Adductor Canal Block | Patient-Reported Itching | 1 occurrence of itching |
Secondary
Patient-Reported Nausea
Total occurrences of patient-reported nausea post-surgery.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Femoral Nerve Block | Patient-Reported Nausea | 3 occurrence of nausea |
| Adductor Canal Block | Patient-Reported Nausea | 2 occurrence of nausea |
Secondary
Patient-Reported Sedation
Total occurrences of patient-reported feelings of sedation post-surgery.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Femoral Nerve Block | Patient-Reported Sedation | 0 occurrence of sedation |
| Adductor Canal Block | Patient-Reported Sedation | 0 occurrence of sedation |
Secondary
Patient-Reported Vomiting
Total occurrences of patient-reported vomiting post-surgery.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Femoral Nerve Block | Patient-Reported Vomiting | 1 occurrence of vomiting |
| Adductor Canal Block | Patient-Reported Vomiting | 1 occurrence of vomiting |
Secondary
Percent of Patients Rating Their Satisfaction as Excellent or Good
Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery.
Time frame: 2 Weeks Post-Surgery
Population: This analysis includes participants who completed the study and used a smartphone application to record study outcome measures following surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Femoral Nerve Block | Percent of Patients Rating Their Satisfaction as Excellent or Good | 39 percentage of participants |
| Adductor Canal Block | Percent of Patients Rating Their Satisfaction as Excellent or Good | 64 percentage of participants |
Secondary
Time to Straight Less Raise
The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Block | Time to Straight Less Raise | 31.7 hours | Standard Deviation 26.1 |
| Adductor Canal Block | Time to Straight Less Raise | 16.4 hours | Standard Deviation 10.5 |
Secondary
Total Hours of Sleep
The total hours of sleep first postoperative night, between 0 to 12 hours.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Block | Total Hours of Sleep | 6.3 hours | Standard Deviation 2 |
| Adductor Canal Block | Total Hours of Sleep | 5.8 hours | Standard Deviation 1.4 |