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Study halted prematurely and will not resume; participants are no longer being examined or receiving any intervention.
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The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection technique (also called a "nerve block") that numbs the nerves going to the side and front of the upper leg will improve pain control after surgery. The SIFI technique uses a numbing solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This block may affect movement in the leg and make the legs weak. The amount of leg weakness is not known and assessment of this will be included in the study. Many institutions use the SIFI block for patients having total hip replacements, with the hope of providing good pain relief combined with improved mobility after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprainguinal Fascia Iliaca (SIFI) block | Experimental | A nerve block technique using a numbing medication called ropivacaine. |
|
| Sham group | Placebo Comparator | The same nerve block technique as above, however using an inactive solution of salt water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suprainguinal fascia iliaca (SIFI) block | Procedure | An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11 | The NRS 11 ranges from 0 (no pain) to 10 (intense pain). | 4 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Opioid Consumption | Reported in IV morphine equivalents. | 24 hours |
| Motor Strength, as Measured by Dynamometry | Reported as pounds per square inch (PSI). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27713 | United States |
Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
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| ID | Title | Description |
|---|---|---|
| FG000 | Suprainguinal Fascia Iliaca (SIFI) Block | A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug) |
| FG001 | Sham Group | The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Suprainguinal Fascia Iliaca (SIFI) Block | A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11 | The NRS 11 ranges from 0 (no pain) to 10 (intense pain). | Posted | Mean | Standard Deviation | score on a scale | 4 hours postoperatively |
|
24 hours from time of block
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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 | Suprainguinal Fascia Iliaca (SIFI) Block | A nerve block technique using a numbing medication called ropivacaine. Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. Ropivacaine: Local anesthetic (numbing drug) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Motor weakness in the quadriceps and adductor group muscles | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Found to be complication of blind acetabular retractor which caused >24hr palsy in the quadriceps and adductor group muscles. Non-intervention induced. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| W. Michael Bullock, MD, PhD | Duke University | 919-668-2024 | william.bullock@duke.edu |
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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 | Dec 11, 2019 | Jun 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| D005457 | Fluoridation |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D000813 | Anilides |
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| Sham block | Procedure | An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. |
|
| Ropivacaine | Drug | Local anesthetic (numbing drug) |
|
|
| Saline | Drug | Salt water placebo |
|
|
| 4 hours postoperatively |
| Numeric Pain Score at 24 Hours, as Measured by NRS 11 | The NRS 11 ranges from 0 (no pain) to 10 (intense pain). | 24 hours |
| Ambulation, as Measured by Distanced Walked | post-op day 0 |
| Sham Group |
The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Cumulative Opioid Consumption | Reported in IV morphine equivalents. | Posted | Mean | Standard Deviation | IV morphine equivalents in mg | 24 hours |
|
|
|
| Secondary | Motor Strength, as Measured by Dynamometry | Reported as pounds per square inch (PSI). | Posted | Mean | Standard Deviation | PSI | 4 hours postoperatively |
|
|
|
| Secondary | Numeric Pain Score at 24 Hours, as Measured by NRS 11 | The NRS 11 ranges from 0 (no pain) to 10 (intense pain). | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
|
|
| Secondary | Ambulation, as Measured by Distanced Walked | Posted | Mean | Standard Deviation | feet | post-op day 0 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Sham Group | The same nerve block technique as above, however using an inactive solution of salt water. Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. Saline: Salt water placebo | 0 | 5 | 0 | 5 | 1 | 5 |
|
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| D012216 |
| Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011313 | Preventive Dentistry |
| D011636 | Public Health Dentistry |
| D004778 | Environment and Public Health |