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Postoperative Pain After Total Knee ArthroplastyNCT07891221

Agreement Between Patient-Reported Pain, Observer-Rated Pain Behavior, and Analgesic Request After Total Knee Arthroplasty

An observational study of Postoperative Pain After Total Knee Arthroplasty, run by Gamze Kübra Zelyurt.

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Trial summary

The goal of this observational study is to learn how well patients' own pain ratings match what an observer sees and whether the patient asks for extra pain medicine after total knee replacement surgery. Read more about this study

Who is it for?
Ages 18 years and older
How many people
120 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 1 May 2027
How long will I take part?
1 Day
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients (18 years or older) undergoing elective primary total knee arthroplasty under spinal anesthesia at Sincan Training and Research Hospital, Ankara, Turkey. Consecutive eligible patients who provide written informed consent will be enrolled.

Who may be able to join

  • Age 18 years or older
  • Scheduled for elective primary total knee arthroplasty
  • Surgery performed under spinal anesthesia
  • Able to undergo postoperative pain assessments
  • Written informed consent

Who cannot join

  • Cognitive impairment or history of dementia
  • Severe hearing or communication impairment
  • Chronic opioid use
  • Serious psychiatric illness
  • Revision knee arthroplasty
  • Conversion to general anesthesia
  • Refusal to participate

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Nagihan Emiroglu, Doctor contact

+905348167688

nagihanyildiz611@gmail.com

Gamze Kubra Zelyurt, Doctor contact

+905544879592

gamzekubra@windowslive.com

About this study

Official title: Agreement Between Patient-Reported Pain Intensity, Observer-Rated Pain Behavior, and Analgesic Request in Postoperative Pain Assessment After Total Knee Arthroplasty: A Prospective Observational Study

The goal of this observational study is to learn how well patients' own pain ratings match what an observer sees and whether the patient asks for extra pain medicine after total knee replacement surgery. The study will include adults aged 18 years or older having planned (elective) total knee replacement under spinal anesthesia.

The main questions it aims to answer are:

Read more
  • Does the pain score reported by the patient (Numeric Rating Scale, 0-10) agree with the patient's request for additional pain medicine?
  • Does the pain score reported by the patient agree with pain behavior rated by an observer (facial expression, body movements, and vocal expressions)?

No treatment will be changed for this study. All patients will receive the hospital's standard anesthesia and pain management.

Participants will:

  • Rate their pain from 0 (no pain) to 10 (worst pain imaginable) at 2, 6, and 24 hours after surgery
  • Be observed by a researcher who scores their pain behavior at the same time points
  • Be asked whether they would like additional pain medicine at each time point
Read the detailed description

Postoperative pain is a major determinant of recovery after total knee arthroplasty (TKA), affecting patient satisfaction, early mobilization, and rehabilitation. The Numeric Rating Scale (NRS) is among the most widely used tools for postoperative pain assessment and frequently guides analgesic decisions. However, pain is a subjective and multidimensional experience, and patients with similar NRS scores may display different levels of pain behavior and analgesic need. Although patient-reported pain intensity, observed pain behavior, and analgesic request have each been studied, few studies have evaluated these three components simultaneously in the early postoperative period.

This single-center, prospective observational study will be conducted at Sincan Training and Research Hospital, Ankara, Turkey. No intervention, randomization, or change in anesthesia or analgesia protocol will be made; all procedures follow routine clinical practice. Written informed consent will be obtained preoperatively.

Adult patients (18 years or older, ASA physical status I-III) undergoing elective primary TKA under spinal anesthesia will be included. Demographic data (age, sex, height, weight), ASA physical status, comorbidities, and perioperative clinical data will be recorded on standardized case report forms.

At postoperative hours 2, 6, and 24:

  1. Patient-reported pain intensity will be assessed with the NRS (0 = no pain, 10 = worst pain imaginable).
  2. Observer-rated pain behavior will be scored with a standardized behavioral pain assessment developed by the investigators, adapted from established behavioral scales (CPOT, FLACC). Facial expression, body movements, and vocal expressions are each scored 0-2 (total score 0-6; higher scores indicate more pronounced pain behavior).
  3. Patients will be asked whether they feel the need for additional analgesia (analgesic request: yes/no).

All patients will receive the institution's standard postoperative multimodal analgesia protocol. Routine analgesics, rescue analgesic administrations, their timing, and total analgesic consumption over the first 24 postoperative hours will be recorded.

Sample size: Based on a power of 90% and a type I error of 5% (G*Power 3.1), assuming a medium effect size, a minimum of 112 patients is required. Allowing for data loss and incomplete records, at least 120 patients will be enrolled.

Statistical analysis: Analyses will be performed with IBM SPSS Statistics. Relationships between NRS, observer-rated pain behavior score, and analgesic request will be analyzed using appropriate parametric or non-parametric tests, including Pearson or Spearman correlation, and chi-square or Fisher's exact test. A p value < 0.05 will be considered statistically significant.

The findings are expected to clarify the clinical validity of numeric pain scores and support a more comprehensive approach to postoperative pain assessment and analgesic decision-making.

Keywords
Numeric Rating Scale, Total Knee Arthroplasty, Pain Measurement, Behavioral Pain Assessment, Analgesic Request

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07891221
Study groupRoleWhat they receive
Total Knee Arthroplasty PatientsAdult patients (18 years or older, ASA I-III) undergoing elective primary total knee arthroplasty under spinal anesthesia. Patient-reported pain (NRS), observer-rated pain behavior, and analgesic request will be assessed at postoperative 2, 6, and 24 hours. No study intervention is applied; all patients receive standard institutional anesthesia and analgesia care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agreement Between Patient-Reported Pain Intensity (NRS) and Observer-Rated Pain Behavior Score

    Observer-rated pain behavior is scored with a standardized behavioral pain assessment adapted from CPOT and FLACC: facial expression, body movements, and vocal expressions, each scored 0-2 (total 0-6; higher scores indicate more pronounced pain behavior). Correlation/agreement with simultaneous NRS scores will be analyzed.

    Measured: Postoperative 2, 6, and 24 hours

Secondary outcomes (1)
  1. Association Between Patient-Reported Pain Intensity (NRS) and Analgesic Request

    Patients rate their current pain on the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) and are asked whether they need additional analgesia (yes/no) at each time point. The association/agreement between NRS scores and analgesic request will be analyzed (e.g., point-biserial/Spearman correlation and comparison of NRS scores between patients who do and do not request analgesia).

    Measured: Postoperative 2, 6, and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07891221
Sponsor's protocol ID
SEAH-BAEK-2026-276
Status last verified
Oct 2026
First submitted
15 Oct 2026
Last updated
23 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly, in accordance with the ethics committee approval and the informed consent, which ensure participant confidentiality. Aggregated results will be published in a peer-reviewed journal.

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