Pain Clinical Trial - Nociceptin Concentration in Synovial Fluid & Plasma

Status Completed

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.

Clinical Trial 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 ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02528916
Study type	Observational
Source	Milton S. Hershey Medical Center
Contact
Status	Completed
Phase	N/A
Start date	April 2014
Completion date	September 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Nociceptin Concentration in Synovial Fluid and Plasma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms