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NCT Number: NCT07457814

Postoperative Pain and Analgesic Use After Total Knee Arthroplasty

This prospective observational study evaluates postoperative pain intensity and analgesic consumption in patients undergoing total knee arthroplasty (TKA) under different anesthesia techniques. Patients receive either general anesthesia with peripheral nerve block, spinal anesthesia with peripheral nerve block, spinal anesthesia alone, or general anesthesia with an epidural catheter. Pain scores (NRS), analgesic use, adverse effects, patient satisfaction, and the need for therapeutic interventions are assessed during the first 48 hours after surgery. The study aims to identify differences in postoperative pain control and factors associated with hypotension and other complications.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tomas Bata regional hospital

Zlín, 76001, Czechia

Location contact

Klára Nekvindová, MD, Ph.D.

CONTACT

+420 577 552 111

About this study

This prospective, monocentric observational study evaluates postoperative pain intensity and analgesic consumption in adult patients undergoing primary total knee arthroplasty (TKA). The study focuses on anesthesia techniques routinely used in clinical practice, including general anesthesia with peripheral nerve block, general anesthesia with an epidural catheter, spinal anesthesia with peripheral nerve block, and spinal anesthesia alone.

The primary methodological aim is to compare postoperative pain trajectories (NRS) and total analgesic use during the first 48 hours after surgery across anesthesia strategies. Secondary observations include adverse effects related to analgesia, patient satisfaction, and the need for therapeutic interventions such as fluid administration, vasopressors, antiemetics, or adjustments in analgesic regimen.

Independent variables include type of anesthesia, ASA physical status, age, sex, BMI, type of peripheral nerve block, and duration of surgery. Dependent variables include postoperative pain scores, analgesic consumption, adverse events, and patient-reported satisfaction.

The study is designed to identify clinically relevant differences in postoperative pain control and to explore factors associated with hypotension and other perioperative complications. Findings may support optimization of perioperative analgesia and guide clinical decision-making in anesthesia management for TKA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-100 years
  • Primary total knee arthroplasty (TKA)
  • ASA physical status I-III
  • Glasgow Coma Scale (GCS) score of 15
  • Ability to understand study procedures and provide informed consent
  • Ability to cooperate during pre-anesthetic evaluation
  • No severe sensory impairment (e.g., blindness, deafness)

Exclusion criteria

  • Revision or reoperation of TKA
  • ASA score IV or higher
  • Refusal to participate or inability to provide informed consent
  • GCS ≤ 14
  • Limited legal capacity
  • Active psychiatric disorder
  • Chronic use of strong opioid analgesics
  • Neurological disease affecting pain perception or cooperation
  • Cognitive impairment or language barrier preventing questionnaire completion
  • Use of anesthesia techniques other than GA + PNB or SA + PNB (e.g., epidural anesthesia, local infiltration without PNB)

Treatment and study plan

Primary outcomes

  1. Postoperative pain intensity

    Time frame: 6 hours, 24 hours, and 48 hours after surgery

    Pain intensity will be assessed using the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) at predefined postoperative intervals. Both scales range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.

    Higher scores represent worse pain intensity.

Secondary outcomes

  1. Analgesic consumption

    Time frame: First 48 hours after surgery

    Total opioid and non-opioid analgesic dose administered within 48 hours postoperatively.

  2. Adverse effects

    Time frame: First 48 hours after surgery

    Incidence of nausea, vomiting, urinary retention, hypotension, and other analgesia-related adverse events.

  3. Patient satisfaction

    Time frame: 48 hours after surgery

    Patient satisfaction with pain control and overall care will be assessed using a 5-point Likert scale, ranging from 1 to 5, where 1 indicates very low satisfaction and 5 indicates very high satisfaction. Higher scores represent better satisfaction.

  4. Length of hospital stay

    Time frame: From the day of surgery (Day 0) through hospital discharge (typically 3-14 days).

    Length of hospital stay will be measured as the number of days from the date of surgery until the date of hospital discharge

  5. Number of participants requiring therapeutic interventions

    Time frame: Up to 48 hours after surgery.

    The need for therapeutic interventions will be recorded, including additional analgesia, intravenous fluids, vasopressors, or other supportive measures administered due to insufficient pain control or hemodynamic instability.

Study contacts

Contact information is provided by the study sponsor or research team.

Klára Nekvindová, MD, Ph.D.

CONTACT

[email protected]

+420 577 552 111

Sponsors and collaborators

Lead sponsor

Tomas Bata Hospital, Czech Republic

Other

Registry information

Official study title

Postoperative Pain and Analgesic Consumption in Patients Undergoing Total Knee Arthroplasty Under General Anesthesia With Peripheral Nerve Block Versus Spinal Anesthesia With Peripheral Nerve Block

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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