Nociceptin Concentration in Synovial Fluid and Plasma

Pain Clinical Trial

Official title:

Nociceptin Concentration in Synovial Fluid and Plasma in Patients Undergoing Primary Total Knee Arthroplasty: A Prospective Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528916
• Other study ID #: 42679
• Status: Completed
• Phase: N/A
• First received: July 5, 2015
• Last updated: March 17, 2016
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

References & Publications (3)

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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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).	No
Secondary	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.	No
Secondary	Patient Demographics	Age	Will be determined in the preoperative period up to one hour prior to surgery.	No
Secondary	Patient Demographics	Gender	Will be determined in the preoperative period up to one hour prior to surgery.	No
Secondary	Patient Demographics	BMI	Will be determined in the preoperative period up to one hour prior to surgery	No
Secondary	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.	No
Secondary	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.	No