Clinical trial NCT02626533: Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis
Official title: Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Joint Stiffness
Keywords: Cytokines
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.

Brief summary: Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. There is growing evidence that inflammation as well as other medical and psychological factors may be associated with osteoarthritis severity, progression, and associated pain severity. This study aims to identify clinical, biological, and psychological factors that contribute to and predict the development of these complications. Identification of such factors may allow us to target preventative measures to the patients at highest risk of persistent postoperative pain and joint stiffness.


Eligibility criteria: Inclusion Criteria:

* Elective primary unilateral total knee arthroplasty
* Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
* Patients of surgeons who have agreed to participate in the study
* Age \> 18 years
* American Society of Anesthesiologists (ASA) Physical Status 1-3
* Regional anesthesia
* Epidural patient-controlled analgesia (PCA) for postoperative pain
* Adductor canal block for postoperative pain

Exclusion Criteria:

* Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
* Use of general anesthesia
* History of \>6 weeks of daily opioid use and/or any use of non-prescribed opioids
* Preoperative oral steroid use in the past 6 months
* Intra-articular steroid injection within one month of scheduled surgery in affected joint
* Non-English speakers
* Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
* Peri-articular injections or infusions for postoperative pain
* Diagnosis of crystalline arthropathy
* Diagnosis of osteonecrosis
* Active infection or use of antibiotics
* Pregnant women

Primary outcomes:
measure: Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS)
timeFrame: 6 months after date of surgery
Secondary outcomes:
measure: Patients Who Experienced Postoperative Joint Stiffness
timeFrame: 6 weeks after date of surgery
measure: Postoperative Knee Range of Motion
timeFrame: 6 weeks after date of surgery
measure: NRS Pain at Rest on POD1
timeFrame: 1 day after surgery
measure: NRS Pain With Movement on POD1
timeFrame: 1 day after surgery
measure: Worst NRS Pain on POD1
timeFrame: 1 day after surgery
measure: Least NRS Pain on POD1
timeFrame: 1 day after surgery
measure: NRS Pain at Rest on POD2
timeFrame: 2 days after surgery
measure: NRS Pain With Movement on POD2
timeFrame: 2 days after surgery
measure: Worst NRS Pain on POD2
timeFrame: 2 days after surgery
measure: Least NRS Pain on POD2
timeFrame: 2 days after surgery
measure: NRS Pain at Rest 4 Weeks After Surgery
timeFrame: 4 weeks after surgery
measure: NRS Pain With Movement 4 Weeks After Surgery
timeFrame: 4 weeks after surgery
measure: Worst NRS Pain 4 Weeks After Surgery
timeFrame: 4 weeks after surgery
measure: Least NRS Pain 4 Weeks After Surgery
timeFrame: 4 weeks after surgery
measure: NRS Pain at Rest 3 Months After Surgery
timeFrame: 3 months after surgery
measure: NRS Pain With Movement 3 Months After Surgery
timeFrame: 3 months after surgery
measure: Worst NRS Pain 3 Months After Surgery
timeFrame: 3 months after date of surgery
measure: Least NRS Pain 3 Months After Surgery
timeFrame: 3 months after date of surgery
measure: NRS Pain at Rest 6 Months After Surgery
timeFrame: 6 months after date of surgery
measure: Least NRS Pain 6 Months After Surgery
timeFrame: 6 months after date of surgery
measure: Worst NRS Pain 6 Months After Surgery
timeFrame: 6 months after date of surgery
measure: Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores
timeFrame: 4 weeks, 3 months, and 6 months after date of surgery
measure: Postoperative painDETECT Scores
timeFrame: 4 weeks, 3 months, and 6 months after date of surgery
measure: Types of Preoperative Medications
timeFrame: Before surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Meghan Kirksey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sideris A, Malahias MA, Birch G, Zhong H, Rotundo V, Like BJ, Otero M, Sculco PK, Kirksey M. Identification of biological risk factors for persistent postoperative pain after total knee arthroplasty. Reg Anesth Pain Med. 2022 Mar;47(3):161-166. doi: 10.1136/rapm-2021-102953. Epub 2021 Dec 17.