Postoperative Pain and Analgesic Use After Total Knee Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorTomas Bata Hospital, Czech Republic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-100 years
Primary total knee arthroplasty (TKA)
ASA physical status I-III
Glasgow Coma Scale (GCS) score of 15
Disqualifiers
Revision or reoperation of TKA
ASA score IV or higher
Refusal to participate or inability to provide informed consent
GCS ≤ 14
Trial population
Adult patients aged 18-100 years undergoing primary total knee arthroplasty at Krajská nemocnice T. Bati, a. s. Patients must have ASA physical status I-III, GCS 15, ability to understand the study procedures, and provide informed consent. Only patients capable of cooperation during pre-anesthetic evaluation and without severe sensory impairment are included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 4 trial groupsGroup A: General Anesthesia + Peripheral Nerve Block (CA + PNB)
Group B: General Anesthesia + Epidural Catheter (CA + EDA)
Group C: Spinal Anesthesia + Peripheral Nerve Block (SA + PNB)
Group D: Spinal Anesthesia (SA)
Trial outcomes
Primary outcomes
1
Postoperative pain intensity
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.
Time frame
6 hours, 24 hours, and 48 hours after surgerySecondary outcomes
1
Analgesic consumption
Total opioid and non-opioid analgesic dose administered within 48 hours postoperatively.
Time frame
First 48 hours after surgery2
Adverse effects
Incidence of nausea, vomiting, urinary retention, hypotension, and other analgesia-related adverse events.
Time frame
First 48 hours after surgery3
Patient satisfaction
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.
Time frame
48 hours after surgery4
Length of hospital stay
Length of hospital stay will be measured as the number of days from the date of surgery until the date of hospital discharge
Time frame
From the day of surgery (Day 0) through hospital discharge (typically 3-14 days).Sponsors and contacts
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Source ClinicalTrials.gov
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