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This randomized, controlled, observer-blinded study clinical trial was designed to evaluate ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular infiltration with ropivacaine for postoperative pain management after total hip arthroplasty.
Despite substantial advances in our understanding of the pathophysiology of pain and availability of newer analgesic techniques, postoperative pain is not always effectively treated. Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Currently, postoperative pain is commonly treated with systemic opioids, which are associated with numerous adverse effects including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and respiratory depression. Use of regional and local anesthesia has been shown to reduce opioid requirements and opioid-related side effects.
Patients undergoing total hip arthroplasty (THA) (n=60) at Parkland and UT Southwestern Medical Center Hospitals will be randomized into one of two groups to receive either ultrasound-guided fascia iliaca compartment block (FICB) with ropivacaine 300 mg and 0.5 mg epinephrine (Group 1) or periarticular infiltration ropivacaine 300 mg and 0.5 mg epinephrine total (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the anesthetic technique (i.e., spinal anesthetic), pre- and postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 48 hours postoperatively.
Patients in Group 1 will receive ultrasound-guided FICB after surgery. Patients in Group 2 will receive ropivacaine via periarticular infiltration prior to closing the incision.
The postoperative analgesia will be documented using the visual analog score (0=no pain, 10=worst pain). In addition, total opioid dose over the 48-h study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea and/or vomiting. All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compartment Block | Active Comparator | Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery |
|
| Infiltration | Active Comparator | Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score at Resting | The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively | Postoperative 48 hours |
| Postoperative Pain Score With Movement | The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively | Postoperative 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours | Total amounts of postoperative opioid requirements for 48 hours postoperatively | Postoperative 48 hours |
| The Time to Ambulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irina Gasanova, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTSW Parkland Health Hospital System | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30700615 | Derived | Gasanova I, Alexander JC, Estrera K, Wells J, Sunna M, Minhajuddin A, Joshi GP. Ultrasound-guided suprainguinal fascia iliaca compartment block versus periarticular infiltration for pain management after total hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2019 Feb;44(2):206-211. doi: 10.1136/rapm-2018-000016. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Compartment Block | Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL Epinephrine: 0.5 mg epinephrine |
| FG001 | Infiltration | Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL Epinephrine: 0.5 mg epinephrine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Compartment Block | Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL Epinephrine: 0.5 mg epinephrine |
| BG001 | Infiltration |
| 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 | Postoperative Pain Score at Resting | The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively | Posted | Median | Inter-Quartile Range | units on a scale | Postoperative 48 hours |
|
Adverse event data were collected during 48 hours postoperatively.
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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 | Compartment Block | Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL Epinephrine: 0.5 mg epinephrine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irina Gasanova | UT Southwestern Medical Center | 4694191997 | Irina.Gasanova@UTSouthwestern.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 | Apr 1, 2016 | Nov 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Epinephrine | Drug | 0.5 mg epinephrine |
|
|
The time to ambulation during 48 hours postoperative period
| Postoperative 48 hours |
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Epinephrine: 0.5 mg epinephrine
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Preoperative Pain Score at Rest | The Visual Analog Pain Score (VAS) on the scale of 10 (0= No pain, 10= Worst pain) at preoperatively | Median | Inter-Quartile Range | units on a scale |
|
| Preoperative Pain Score with Cough | The Visual Analog Pain Score (VAS) with cough on the scale of 10 (0= No pain, 10= Worst pain) preoperatively | Median | Inter-Quartile Range | units on a scale |
|
|
|
|
| Primary | Postoperative Pain Score With Movement | The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively | Posted | Mean | Inter-Quartile Range | units on a scale | Postoperative 48 hours |
|
|
|
|
| Secondary | Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours | Total amounts of postoperative opioid requirements for 48 hours postoperatively | Posted | Mean | Standard Deviation | Oral Morphine Equivalent (mg) | Postoperative 48 hours |
|
|
|
|
| Secondary | The Time to Ambulation | The time to ambulation during 48 hours postoperative period | Posted | Median | Inter-Quartile Range | Hours | Postoperative 48 hours |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Infiltration | Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision Ropivacaine: Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL Epinephrine: 0.5 mg epinephrine | 0 | 30 | 0 | 30 | 0 | 30 |
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| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |