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Completed

NCT Number: NCT02528916

Nociceptin Concentration in Synovial Fluid and Plasma

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.

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Key information

About this study

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:

  • 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.
  • 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.
  • Determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty.

Secondary Study Endpoints:

  • 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.
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. Patient Demographics

    Time frame: Will be determined in the preoperative period up to one hour prior to surgery.

    Age

  4. Patient Demographics

    Time frame: Will be determined in the preoperative period up to one hour prior to surgery.

    Gender

  5. Patient Demographics

    Time frame: Will be determined in the preoperative period up to one hour prior to surgery

    BMI

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2015
Registry last updated
Mar 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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