Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Nociceptin/Orphanin is a novel opioid peptide system associated with inflammatory response. Currently is it uncertain as to the presence of absence of nociceptin in synovial fluid of patients. Nociceptin levels will be measured pre-operatively and post-operatively in plasma levels of patients receiving primary total knee arthroplasty. Nociceptin levels will also be measured in synovial fluid levels prior to surgical manipulation.
This is a prospective observational study where nociceptin levels will be drawn from the patient's serum as well as from the patient's synovial fluid. The blood draws will be completed by the anesthesia team and the synovial fluid and tissue will be obtained by the orthopedic team. The initial blood draw will be in the preoperative area and the second blood draw will be five minutes after the release of the tourniquet. The synovial fluid will be drawn by the surgeon with the first incision. There will be no randomization nor control group.
Endpoints:
Secondary Study Endpoints:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Knee Arthroplasty Patients | Patients who consented, met inclusion and exclusion criteria, had plasma and synovial fluid samples drawn as described in the included protocol. No interventions were completed. No changes to standard of care treatment completed. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Nociceptin in Synovial Fluid | The level or absence of nociceptin in synovial fluid will be measured using ELISA and represented in picograms per volume. | The surgeon will make a small incision after the patient has been anesthetized and prepped and draped. He will then withdraw the synovial fluid and then will begin the surgery after the fluid is removed. |
| Measure | Description | Time Frame |
|---|---|---|
| Nociceptin in Plasma | Determine the presence of absence of nociceptin in plasma in patients receiving total knee primary arthroplasty and determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty. Nociceptin will be measured using ELISA and represented in terms of picograms per volume. | Blood will be drawn in the preoperative period (approximately up to 1 hour prior to surgery). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Sequential patients receiving primary unilateral knee arthroplasty by the same surgeon
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17266536 | Background | Chiou LC, Liao YY, Fan PC, Kuo PH, Wang CH, Riemer C, Prinssen EP. Nociceptin/orphanin FQ peptide receptors: pharmacology and clinical implications. Curr Drug Targets. 2007 Jan;8(1):117-35. doi: 10.2174/138945007779315605. | |
| 23421672 | Background | Lin AP, Ko MC. The therapeutic potential of nociceptin/orphanin FQ receptor agonists as analgesics without abuse liability. ACS Chem Neurosci. 2013 Feb 20;4(2):214-24. doi: 10.1021/cn300124f. Epub 2012 Nov 6. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
Not provided
Not provided
Not provided
Not provided
Not provided
| Nociceptin in Plasma | Determine the presence of absence of nociceptin in plasma in patients receiving total knee primary arthroplasty and determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty. Nociceptin will be measured using ELISA and represented in terms of picograms per volume. | Blood will be drawn 5 minutes after the release of the tourniquet. |
| Patient Demographics | Age | Will be determined in the preoperative period up to one hour prior to surgery. |
| Patient Demographics | Gender | Will be determined in the preoperative period up to one hour prior to surgery. |
| Patient Demographics | BMI | Will be determined in the preoperative period up to one hour prior to surgery |
| Patient Pain Scores | pre-operative pain scores will be determined using the 0-10 verbal analog scale. | One set of preoperative scores will be obtained up to one hour prior to surgery. |
| Patient Pain Scores | post-operative pain scores will be determined using the 0-10 verbal analog scale. | One set of post operative pain scores will be obtained up to one hour post emergence from anesthesia. |
| 10655922 | Result | Kumar N, Smart D, Mason S, McKnight AT, Rowbotham DJ, Lambert DG. Neither nociceptin nor its receptor are present in human synovial fluid or tissue. Br J Anaesth. 1999 Sep;83(3):470-1. doi: 10.1093/bja/83.3.470. |
| 32677997 | Derived | Verbeek TA, Jarbadan NR, Davis C, Caldwell J. Nociceptin is present in synovial fluid of patients undergoing total knee arthroplasty. J Orthop Surg Res. 2020 Jul 16;15(1):266. doi: 10.1186/s13018-020-01789-1. |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |