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

NCT07891221 | Not Yet Recruiting

• 1 other identifier: SEAH-BAEK-2026-276
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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:

• 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

Conditions

Postoperative Pain After Total Knee Arthroplasty

Keywords

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

Outcome Measures

Primary Outcomes (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.

  Postoperative 2, 6, and 24 hours

Secondary Outcomes (1)

• Association Between Patient-Reported Pain Intensity (NRS) and Analgesic Request

  Postoperative 2, 6, and 24 hours

Study Arms (1)

Total Knee Arthroplasty Patients

Adult 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gamze Kübra Zelyurt: lead

Study Officials

• Nagihan Emiroglu

  Sincan Training and Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nagihan Emiroglu, Doctor

CONTACT

+905348167688; nagihanyildiz611@gmail.com

Gamze Kubra Zelyurt, Doctor

CONTACT

+905544879592; gamzekubra@windowslive.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Doctor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share