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PI leaving the institution, no subjects enrolled since 2019, and no other PI interested in taking it over.
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This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block involved with sciatic nerve block. The lack of motor block is important to facilitate postoperative ambulation and physical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FNB-AC + Sciatic nerve block | Active Comparator | Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance. |
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| FNB-AC + IPACK | Experimental | Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine injection | Drug | Total dose not to exceed 3 mg/kg of ropivacaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Post-operative Pain Score | Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center. | Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Opioid Doses Administered | Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center. | Intra-operative and up to 48 hours post-discharge, an average of 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FNB-AC + Sciatic Nerve Block | Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance. Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine. |
| FG001 | FNB-AC + IPACK | Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK) Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FNB-AC + Sciatic Nerve Block | Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance. Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine. |
| BG001 | FNB-AC + IPACK |
| 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 | Average Post-operative Pain Score | Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours |
|
48 hours
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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 | FNB-AC + Sciatic Nerve Block | Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance. Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Rice-Weimer, RN | Nationwide Children's Hospital | 614-355-3142 | julie.rice-weimer@nationwidechildren.org |
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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 | Mar 15, 2021 | Jul 15, 2021 | Prot_SAP_000.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 |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK) Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
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| Secondary | Number of Opioid Doses Administered | Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center. | Posted | Mean | Full Range | opiod doses administered | Intra-operative and up to 48 hours post-discharge, an average of 48 hours |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | FNB-AC + IPACK | Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK) Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D000588 |
| Amines |