Clinical trial NCT02528916: Nociceptin Concentration in Synovial Fluid and Plasma
Official title: Nociceptin Concentration in Synovial Fluid and Plasma in Patients Undergoing Primary Total Knee Arthroplasty: A Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Osteoarthritis
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sequential patients receiving primary unilateral knee arthroplasty by the same surgeon

Brief summary: 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.

Detailed description: 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:

1. The level or absence of nociceptin in synovial fluid in patients receiving total knee primary arthroplasty will be measured via ELISA in picograms per volume.
2. The level or absence of nociceptin in plasma in patients receiving total knee primary arthroplasty both in the preoperative period (less than 1 hour prior to surgery and 5 minutes after the tourniquet is removed) via ELISA in picograms per volume.
3. Determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty.

Secondary Study Endpoints:

1. Determine the effect if present of history of chronic pain and opioid use on the levels of nociception present in patients' synovial fluid and plasma receiving primary total knee arthroplasty.
2. Determine the effect if present of demographic factors on the levels of nociception present in patients' synovial fluid and plasma receiving primary total knee arthroplasty

Eligibility criteria: Inclusion Criteria:

* receiving a primary knee joint arthroplasty by Dr. Davis ages 18-80 years hemodynamically stable no joint or other types of infection informed consent received and signed no prior joint arthroplasty at the current surgical site no other surgical intervention planned

Exclusion Criteria:

* prior knee arthroplasty at site outside of desired age range pregnant current infection in joint or other location no desire to participate

Primary outcomes:
measure: Nociceptin in Synovial Fluid
timeFrame: 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.
Secondary outcomes:
measure: Nociceptin in Plasma
timeFrame: Blood will be drawn in the preoperative period (approximately up to 1 hour prior to surgery).
measure: Nociceptin in Plasma
timeFrame: Blood will be drawn 5 minutes after the release of the tourniquet.
measure: Patient Demographics
timeFrame: Will be determined in the preoperative period up to one hour prior to surgery.
measure: Patient Demographics
timeFrame: Will be determined in the preoperative period up to one hour prior to surgery.
measure: Patient Demographics
timeFrame: Will be determined in the preoperative period up to one hour prior to surgery
measure: Patient Pain Scores
timeFrame: One set of preoperative scores will be obtained up to one hour prior to surgery.
measure: Patient Pain Scores
timeFrame: One set of post operative pain scores will be obtained up to one hour post emergence from anesthesia.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.