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Nociceptin Concentration in Synovial Fluid and Plasma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02528916
First Posted: August 19, 2015
Last Update Posted: March 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Julia Caldwell, Milton S. Hershey Medical Center
  Purpose
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.

Condition
Pain Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nociceptin Concentration in Synovial Fluid and Plasma in Patients Undergoing Primary Total Knee Arthroplasty: A Prospective Pilot Study

Further study details as provided by Julia Caldwell, Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Nociceptin in Synovial Fluid [ Time Frame: 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. ]
    The level or absence of nociceptin in synovial fluid will be measured using ELISA and represented in picograms per volume.


Secondary Outcome Measures:
  • Nociceptin in Plasma [ Time Frame: Blood will be drawn in the preoperative period (approximately up to 1 hour prior to surgery). ]
    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.

  • Nociceptin in Plasma [ Time Frame: Blood will be drawn 5 minutes after the release of the tourniquet. ]
    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.

  • Patient Demographics [ Time Frame: Will be determined in the preoperative period up to one hour prior to surgery. ]
    Age

  • Patient Demographics [ Time Frame: Will be determined in the preoperative period up to one hour prior to surgery. ]
    Gender

  • Patient Demographics [ Time Frame: Will be determined in the preoperative period up to one hour prior to surgery ]
    BMI

  • Patient Pain Scores [ Time Frame: One set of preoperative scores will be obtained up to one hour prior to surgery. ]
    pre-operative pain scores will be determined using the 0-10 verbal analog scale.

  • Patient Pain Scores [ Time Frame: One set of post operative pain scores will be obtained up to one hour post emergence from anesthesia. ]
    post-operative pain scores will be determined using the 0-10 verbal analog scale.


Enrollment: 22
Study Start Date: April 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Sequential patients receiving primary unilateral knee arthroplasty by the same surgeon
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Julia Caldwell, Assistant Professor of Anesthesiology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02528916     History of Changes
Other Study ID Numbers: 42679
First Submitted: July 5, 2015
First Posted: August 19, 2015
Last Update Posted: March 18, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Nociceptin
Nocistatin
Vasodilator Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents