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Double-blind, randomized controlled clinical trial to test the efficacy of IPACK on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral TKA.
Enrolled patients will be randomized to either continuous ACB with IPACK or to continuous ACB with sham subcutaneous saline injection. Outcomes assessors and patients will be blinded to the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuous ACB with IPACK block | Active Comparator | ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and IPACK block with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine |
|
| continuous ACB with sham subcutaneous saline injection | Sham Comparator | ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and a sham IPACK block with subcutaneous saline injection along the medial thigh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative opioid consumption (morphine equivalents) in the first 24 hours | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey | through study completion approximately 2 days | |
| Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm | through study completion approximately 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Patterson, MD | Ochsner | Principal Investigator |
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No plan
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 17, 2016 | Apr 10, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2016 | Apr 15, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Only the regional anesthesiologist performing the block will know the randomization status. The study participants, outcome assessors/researchers, other anesthesia personnel, surgeons, physician assistants, and nurses will be blinded to the treatment arm.
|
|
| Saline | Drug | All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily. |
|
| Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm | through study completion approximately 2 days |
| Walk distance on POD#1 am, POD#1 pm, POD#2 | through study completion approximately 2 days |
| Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room | through study completion approximately 2 days |
| Time to oral-only opioids | through study completion approximately 2 days |
| Pain location | through study completion approximately 2 days |
| Hospital length of stay | through study completion approximately 2 days |
| Incidence of foot drop | through study completion approximately 2 days |
| Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm | through study completion approximately 2 days |
| Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score | through study completion approximately 2 days |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |