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The investigators will be randomizing patients to either receive an adductor canal block in the operating room postoperatively as single shot of 20-30cc bupivacaine or to have a catheter inserted into the adductor canal which will be attached up to a continuous infusion pump of bupivacaine that will have a set flow rate over the next couple days. The investigators' hypothesis is that patients will have better pain control, sleep, and decreased opioid consumption with the use of a continuous infusion pump
Screening evaluation will occur during the preoperative visit prior to surgery which generally occurs within 28 days prior to surgery. No separate screening is indicated in this study.
Patients will be asked to participate in the study if they are having ACL Reconstruction surgery with one of the orthopedic surgeons who is participating in the study. They will be informed and consented in the office or in the preoperative holding area prior to surgery.
Patients undergo ACL reconstruction at either Plainview, Franklin, Huntington, Long Island Jewish, or North Shore University Hospital.
Any medical condition that is present at the time that the participant is screened will be considered as baseline and not reported as an adverse event (AE). However, if the study participant's condition deteriorates at any time during the study, it will be recorded as an AE.
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each level of severity to be performed. AEs characterized as intermittent require documentation of onset and duration of each episode.
The investigator who is making phone calls to the given participant will record all reportable events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit/phone call, the investigator will inquire about the occurrence of AE/SAEs since the last visit/phone call. Events will be followed for outcome information until resolution or stabilization.
Study procedures and evaluations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Shot | Active Comparator | Patients will receive an adductor canal block in the operating room postoperatively as single shot of 20-30cc bupivacaine |
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| Continuous Block | Active Comparator | Patients will have a catheter inserted into the adductor canal which will be attached up to a continuous infusion pump of bupivacaine that will have a set flow rate over the next couple days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Administered by an anesthesiologist or certified nurse anesthetist, under ultrasound guidance a catheter placed overlying the nerve sheath. This catheter is then connected to a device with a reservoir that administers local anesthetic at a set rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Rest | Measured by a visual analogue scale (1-10) | Day 1 |
| Pain at Rest | Measured by a visual analogue scale (1-10) | Day 2 |
| Pain at Rest | Measured by a visual analogue scale (1-10) | Day 3 |
| Pain at Rest | Measured by a visual analogue scale (1-10) | Day 4 |
| Pain at Rest | Measured by a visual analogue scale (1-10) | Day 7 |
| Pain at Rest | Measured by a visual analogue scale (1-10) | Day 14 |
| Worst Pain in the past 24 hours | Measured by visual analogue scale 1-10 | Day 1 |
| Worst Pain in the past 24 hours | Measured by visual analogue scale 1-10 | Day 2 |
| Worst Pain in the past 24 hours | Measured by visual analogue scale 1-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Opioid Consumption | This will be measured as daily consumption of oxycodone (morphine equivalents) | on post operative day 1,2,3,4,7, and 14 |
| Incidence of Disturbed Sleep | Measured this by asking if they had a disturbance in their sleep or trouble getting to sleep because of pain in the surgical knee |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randy Cohn, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plainview Hospital | Plainview | New York | 11803 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2020 | Oct 16, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2020 | Oct 16, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Day 3 |
| Worst Pain in the past 24 hours | Measured by visual analogue scale 1-10 | Day 4 |
| Worst Pain in the past 24 hours | Measured by visual analogue scale 1-10 | Day 7 |
| Worst Pain in the past 24 hours | Measured by visual analogue scale 1-10 | Day 14 |
| on post operative day 1,2,3,4,7, and day 14 |
| IKDC - International Knee Documentation Commitee Form for Knee Function | Subjective validated scoring form for knee function. Scale 0-10. 0 for not being able to perform any function. 10 being no limitation in function | Preoperatively, 3 months, 6 months |
| Rand Short Form - 36 | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate. The eight sections are: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health | Preoperatively, 3 months, 6 months |
| D000588 |
| Amines |