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| ID | Type | Description | Link |
|---|---|---|---|
| PSI-07-52 |
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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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Despite the development of new pain medications, the prevalence of persistent postoperative pain (for more than three to six months) remains alarmingly high. Chronic pain and reduced function after surgery are of great concern since they have a significant impact on a patient's quality of life and are costly to society in terms of longer hospital stays and lost work days. An important risk factor for chronic pain and reduced function after surgery is the amount of pain patients experience immediately after surgery which is highly influenced by the amount of pain patients have preoperatively. For many patients, longstanding pain prior to surgery is common and thus can compromise the outcome of the procedure. Therefore, the aim of this study is to reduce the amount of pain patients have before they undergo surgery by administering a novel pain-relieving regimen in the weeks before surgery. Crucially, this treatment will be continued for three weeks after surgery to reduce pain that arises from the surgical trauma. The novel regimen will include a non-steroidal anti-inflammatory (celecoxib) and the alpha2 delta ligand, pregabalin. This drug combination will provide the best opportunity to target several key sites in the pain pathway. This regimen will be tested in patients with pain related to osteoarthritis and who are undergoing orthopedic (hip) surgery because chronic preoperative pain is common in these patients and is the main reason for undergoing surgery. The goal of this research proposal is to adequately manage pain before and after surgery in order to improve function weeks after surgery. If controlling pain in this way does lead to improved long term postoperative function the findings from this study may lead to the development of a standardized regimen. This is highly relevant not only for orthopedic procedures but following other common surgical procedures which would be of great benefit to patients and the entire healthcare system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Prospective, single center, randomized, double-blinded, placebo controlled study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin, Celecoxib | Drug | Pregabalin (75mg BID) and Celecoxib(100mg BID) two weeks prior to hip arthroplasty and 3 weeks postoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical function | 6 weeks postop |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pre and postoperatively (up to 6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 1, 2013 | |
| Reset | Apr 10, 2013 | |
| Release | Apr 12, 2013 | |
| Reset | May 21, 2013 | |
| Release | May 21, 2013 | |
| Unrelease | Yes | |
| Release | Jun 6, 2013 | |
| Reset | Jul 10, 2013 | |
| Release | Aug 13, 2013 | |
| Reset | Oct 18, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 1, 2013 | Apr 10, 2013 | |||
| Apr 12, 2013 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| May 21, 2013 |
| May 21, 2013 | Yes |
| Jun 6, 2013 | Jul 10, 2013 |
| Aug 13, 2013 | Oct 18, 2013 |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |