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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000135 | U.S. NIH Grant/Contract | View source |
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The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.
Patients undergoing total knee replacement will be assigned at random to receive one of two methods of postoperative pain management. Patients assigned to nerve block will receive regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block. Patients assigned to periarticular injection will receive periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Additionally, all patients will be given a standardized combination of oral analgesic medications preoperatively and postoperatively. All patients will receive a posterior stabilized total knee replacement through an medial parapatellar approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerve Block | Experimental | Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. |
|
| Periarticular Injection | Active Comparator | Injection combination prior to skin closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve Block | Drug | Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Pain | Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain). | Afternoon on post-operative Day 1, approximately 14:00 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment) | Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain). | Afternoon on post-operative Day 1, approximately 14:00 |
| Narcotic Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Spangehl, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24706022 | Result | Spangehl MJ, Clarke HD, Hentz JG, Misra L, Blocher JL, Seamans DP. The Chitranjan Ranawat Award: Periarticular injections and femoral & sciatic blocks provide similar pain relief after TKA: a randomized clinical trial. Clin Orthop Relat Res. 2015 Jan;473(1):45-53. doi: 10.1007/s11999-014-3603-0. |
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Subjects were recruited from Mayo Clinic, Phoenix, Arizona from September 2010 to February 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nerve Block | Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine. |
| FG001 | Periarticular Injection | Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nerve Block | Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine. |
| BG001 | Periarticular Injection |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment) | Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain). | In the nerve block arm 5 subjects were excluded (3 subjects were not treated as planned, and 1 subject received a sciatic catheter instead of a single injection, and 1 subject previously had a nerve block procedure.) In the periarticular injection arm 4 patients were excluded (3 subjects were not treated as planned, and 1 subject was too heavy.) | Posted | Mean | Standard Deviation | units on a scale | Afternoon on post-operative Day 1, approximately 14:00 |
|
Adverse events were collected from within 4 days of the surgery.
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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 | Nerve Block | Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Pulmonary Embolism | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
Participants and staff could not be blinded to the treatment arm received; participants' pain was evaluated at rest and not with activity; the study was not powered to identify certain rare events such as falls.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark J. Spangehl, M.D. | Mayo Clinic | 480-342-2377 | spangehl.mark@mayo.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
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|
| Periarticular Injection | Drug | Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories. |
|
|
Use of additional narcotic medications (as needed), measured in morphine equivalents. |
| Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2 |
| Straight-leg Raise | Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise. | Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon |
| Length of Stay in Hospital | Length of stay data were calculated from the medical record. | Approximately 2 days after surgery |
| Number of Subjects Who Experienced Neurological Changes Postoperatively | Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively. | 6 weeks postoperative |
Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Periarticular Injection | Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories. |
|
|
|
| Primary | Post-Operative Pain | Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain). | Intention to treat analysis | Posted | Mean | Standard Deviation | units on a scale | Afternoon on post-operative Day 1, approximately 14:00 |
|
|
|
|
| Secondary | Narcotic Use | Use of additional narcotic medications (as needed), measured in morphine equivalents. | Intention to treat analysis | Posted | Mean | Standard Deviation | mg | Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2 |
|
|
|
|
| Secondary | Straight-leg Raise | Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise. | The number of participants analyzed varied at each category time point because either data points were missing for participants, or as the condition of the participants improved, they were discharged from the hospital. Number of participants per arm for each time point is shown in each category label. | Posted | Number | participants | Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon |
|
|
|
|
| Secondary | Length of Stay in Hospital | Length of stay data were calculated from the medical record. | The number of participants analyzed were different than the baseline values for the arms because data were not available for some participants. | Posted | Mean | Standard Deviation | days | Approximately 2 days after surgery |
|
|
|
|
| Secondary | Number of Subjects Who Experienced Neurological Changes Postoperatively | Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively. | The number of participants analyzed in the nerve block arm varied because data were not available for all participants in all neurological categories. The sample size for the periarticular injection arm was 79 because neurological data were not collected on 2 participants. | Posted | Number | participants | 6 weeks postoperative |
|
|
|
|
| 4 |
| 79 |
| 55 |
| 79 |
| EG001 | Periarticular Injection | Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories. | 0 | 81 | 54 | 81 |
| Acute Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Lumbar Vertebral Fracture After Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stroke Middle Cerebral Artery | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Syncope | Ear and labyrinth disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| 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 |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 2-Sided |
| No |
| Superiority or Other |
| Post-Operative Day 1 |
|
| Post-Operative Day 2 |
|
| <0.001 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison of arms for narcotic use on post operative day 1 as needed. | t-test, 2 sided | 0.17 | 2-Sided | No | Superiority or Other |
| Comparison of arms for narcotic use on post operative day 2 as needed. | t-test, 2 sided | 0.51 | 2-Sided | No | Superiority or Other |
| Day 2 AM (Nerve Block=78, Injection=79) |
|
| Day 2 PM (Nerve Block=69, Injection=51) |
|
| <0.001 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison between arms for postoperative day 2 morning. | t-test, 2 sided | 0.002 | 2-Sided | No | Superiority or Other |
| Comparison between arms for postoperative day 2 afternoon. | t-test, 2 sided | 0.97 | 2-Sided | No | Superiority or Other |
| Tibial nerve (nerve block n=78) |
|
| Femoral, peroneal, or tibial (nerve block n=77) |
|
| 0.01 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison between arms for tibial nerve. | t-test, 2 sided | 0.62 | 2-Sided | No | Superiority or Other |
| Comparison between arms for femoral, peroneal, or tibial nerves. | t-test, 2 sided | 0.009 | 2-Sided | No | Superiority or Other |