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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral Nerve Block | Active Comparator | Subjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery. |
|
| Adductor Canal Block | Active Comparator | Subjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.5% | Drug | Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-surgery (day of surgery to 6 days post-surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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, | Post surgery, Day 0 to Day 6 |
| Total Hours of Sleep |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Xerogeanes, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Healthcare Orthopaedics and Spine Center | Atlanta | Georgia | 30329 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Femoral Nerve Block | Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the femoral nerve. |
| FG001 | Adductor Canal Block | Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the adductor canal |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who consented to take part in the trial and received the intervention of the study arm they were randomized to.
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| ID | Title | Description |
|---|---|---|
| BG000 | Femoral Nerve Block | Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve. |
| BG001 | Adductor Canal Block | Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This analysis includes participants who completed the study and used a smartphone application to record pain level for 6 days post-surgery. | Posted | Mean | Standard Deviation | units on a scale | Post-surgery (day of surgery to 6 days post-surgery) |
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Data regarding adverse events were collected from the time a participant gave informed consent to take part in the study until the end of the study follow up.
Any change from baseline considered by the investigator to be an untoward medical occurrence different from the standard of care, was reported as an adverse event. Any change from baseline considered by the investigator to be part of the normal daily fluctuations of the underlying disease process, was not reported as an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Femoral Nerve Block | Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve. |
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Data collection with a paper journal was low, resulting in the study switching to a smartphone application for participant record keeping. The data analyses include participants who enrolled after the smartphone application became available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Xerogeanes, MD | Emory University | 404-778-7202 | jxeroge@emory.edu |
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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Percocet 7.5/325 | Drug | Percocet 7.5/325 will taken as needed up to every four hours. |
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| Naprosyn 500 mg | Drug | Naprosyn 500 mg will be taken twice daily. |
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The total hours of sleep first postoperative night, between 0 to 12 hours. |
| First Postoperative Night (up to 12 hours) |
| Patient-Reported Nausea | Total occurrences of patient-reported nausea post-surgery. | Post-Surgery (up to 6 days) |
| Patient-Reported Vomiting | Total occurrences of patient-reported vomiting post-surgery. | Post-Surgery (up to 6 days) |
| Patient-Reported Constipation | Total occurrences of patient-reported constipation post-surgery. | Post-Surgery (up to 6 days) |
| Patient-Reported Sedation | Total occurrences of patient-reported feelings of sedation post-surgery. | Post-Surgery (up to 6 days) |
| Patient-Reported Itching | Total occurrences of patient-reported itching post-surgery. | Post-Surgery (up to 6 days) |
| 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. | Post-Surgery (up to 6 days) |
| 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. | 2 Weeks Post-Surgery |
| Incomplete data using paper journal |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Adductor Canal Block | Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal |
|
|
| 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, | 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. | Posted | Mean | Standard Deviation | count of tablets | Post surgery, Day 0 to Day 6 |
|
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| Secondary | Total Hours of Sleep | The total hours of sleep first postoperative night, between 0 to 12 hours. | 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. | Posted | Mean | Standard Deviation | hours | First Postoperative Night (up to 12 hours) |
|
|
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| Secondary | Patient-Reported Nausea | Total occurrences of patient-reported nausea post-surgery. | This analysis includes participants completing the study who used a smartphone application for 6 days post-operatively to record every time they experienced nausea. | Posted | Number | occurrence of nausea | Post-Surgery (up to 6 days) |
|
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| Secondary | Patient-Reported Vomiting | Total occurrences of patient-reported vomiting post-surgery. | 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. | Posted | Number | occurrence of vomiting | Post-Surgery (up to 6 days) |
|
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| Secondary | Patient-Reported Constipation | Total occurrences of patient-reported constipation post-surgery. | 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. | Posted | Number | occurrence of constipation | Post-Surgery (up to 6 days) |
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| Secondary | Patient-Reported Sedation | Total occurrences of patient-reported feelings of sedation post-surgery. | 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. | Posted | Number | occurrence of sedation | Post-Surgery (up to 6 days) |
|
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| Secondary | Patient-Reported Itching | Total occurrences of patient-reported itching post-surgery. | 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. | Posted | Number | occurrence of itching | Post-Surgery (up to 6 days) |
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| 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. | 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. | Posted | Mean | Standard Deviation | hours | Post-Surgery (up to 6 days) |
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| 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. | This analysis includes participants who completed the study and used a smartphone application to record study outcome measures following surgery. | Posted | Number | percentage of participants | 2 Weeks Post-Surgery |
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| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Adductor Canal Block | Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal | 0 | 59 | 0 | 59 | 0 | 59 |
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| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| Post-surgery Day 2 |
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| Post-surgery Day 3 |
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| Post-surgery Day 4 |
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| Post-surgery Day 5 |
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| Post-surgery Day 6 |
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