Tomas Bata regional hospital
Zlín, 76001, Czechia
NCT Number: NCT07457814
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.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Observational
Zlín, 76001, Czechia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: First 48 hours after surgery
Total opioid and non-opioid analgesic dose administered within 48 hours postoperatively.
Time frame: First 48 hours after surgery
Incidence of nausea, vomiting, urinary retention, hypotension, and other analgesia-related adverse events.
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.
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
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.
Contact information is provided by the study sponsor or research team.
Tomas Bata Hospital, Czech Republic
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07588958
Postoperative Pain After Total Knee Arthroplasty
Zagazig, Alsharqia, Egypt
View Trial DetailsNCT07547618
Agnosia, Analgesic Consumption
Ankara, Yenimahalle, Turkey (Türkiye)
View Trial DetailsNCT07726550
Agnosia, Nervous System Diseases
Tekirdağ, Turkey (Türkiye)
View Trial DetailsNCT07659665
Agnosia, Analgesia
Sanaa, Yemen
View Trial Details