Reliability of Pupil Response to Acute Pain
NCT02628314
Arthritis, Joint Diseases
Winston-Salem, North Carolina, United States
View Trial DetailsNCT Number: NCT02528916
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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Notify Me18 year–80 year
All sexes
Observational
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:
Secondary Study Endpoints:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Will be determined in the preoperative period up to one hour prior to surgery.
Age
Time frame: Will be determined in the preoperative period up to one hour prior to surgery.
Gender
Time frame: Will be determined in the preoperative period up to one hour prior to surgery
BMI
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.
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.
Milton S. Hershey Medical Center
Other
Nociceptin Concentration in Synovial Fluid and Plasma in Patients Undergoing Primary Total Knee Arthroplasty: A Prospective Pilot Study
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