Postoperative Pain After Total Knee ArthroplastyNCT07457814
Postoperative Pain and Analgesic Use After Total Knee Arthroplasty
An observational study of Postoperative Pain After Total Knee Arthroplasty and Postoperative Pain, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.
Trial summary
This prospective observational study evaluates postoperative pain intensity and analgesic consumption in patients undergoing total knee arthroplasty (TKA) under different anesthesia techniques. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain After Total Knee Arthroplasty, Postoperative Pain, Analgesic Consumption
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2026to 15 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Tomas Bata regional hospital
Zlín, 76001
Klára Nekvindová, MD, Ph.D., +420 577 552 111
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Postoperative Pain After Total Knee Arthroplasty, Postoperative Pain, Analgesic Consumption
- Keywords
- Total Knee Arthroplasty, Postoperative Pain, Anesthesia Techniques, Analgesic Consumption, Epidural Analgesia, Opioid Use, General Anesthesia, Spinal Anesthesia, Pain Management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia + Peripheral Nerve Block (CA + PNB) | Patients undergoing total knee arthroplasty under general anesthesia combined with a peripheral nerve block. General anesthesia is induced using intravenous and inhalational agents. A peripheral nerve block (most commonly femoral or saphenous) is administered preoperatively to reduce postoperative pain and opioid requirements. This group represents a commonly used multimodal analgesic approach in routine clinical practice. | |
| General Anesthesia + Epidural Catheter (CA + EDA) | Patients undergoing total knee arthroplasty under general anesthesia with an epidural catheter placed for intraoperative and postoperative analgesia. General anesthesia is induced using intravenous and inhalational agents. The epidural catheter allows continuous administration of analgesics and individualized dose adjustment to maintain postoperative pain control. This group represents a commonly used technique for providing extended regional analgesia following TKA. | |
| Spinal Anesthesia + Peripheral Nerve Block (SA + PNB) | Patients undergoing total knee arthroplasty under spinal anesthesia supplemented with a peripheral nerve block. Spinal anesthesia is administered into the subarachnoid space to provide intraoperative analgesia. A peripheral nerve block (femoral or saphenous) is added to enhance postoperative pain control and reduce the need for systemic analgesics. This combination represents a commonly used multimodal analgesic strategy. | |
| Spinal Anesthesia (SA) | Patients receiving spinal anesthesia alone without an additional peripheral nerve block. Spinal anesthesia provides sensory and motor blockade of the lower body during surgery. This group allows evaluation of postoperative pain and analgesic requirements in patients managed with spinal anesthesia as the sole regional technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours, 24 hours, and 48 hours after surgery
Secondary outcomes (5)
Analgesic consumption
Total opioid and non-opioid analgesic dose administered within 48 hours postoperatively.
Measured: First 48 hours after surgery
Adverse effects
Incidence of nausea, vomiting, urinary retention, hypotension, and other analgesia-related adverse events.
Measured: First 48 hours after surgery
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.
Measured: 48 hours after surgery
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
Measured: From the day of surgery (Day 0) through hospital discharge (typically 3-14 days).
Number of participants requiring therapeutic interventions
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.
Measured: Up to 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain After Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomas Bata Hospital, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klára Nekvindová, Tomas Bata Hospital, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457814
- Sponsor's protocol ID
- 2026-01
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "Individual participant data will not be shared because the study involves sensitive clinical information and no data-sharing plan was included in the ethics committee approval. Data will be used exclusively for the purposes of this study."
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07457814
- Acronym / sponsor ID
- 2026-01
- Conditions
- Postoperative Pain After Total Knee Arthroplasty, Postoperative Pain, Analgesic Consumption
- Keywords
- Total Knee Arthroplasty, Postoperative Pain, Anesthesia Techniques, Analgesic Consumption, Epidural Analgesia, Opioid Use, General Anesthesia, Spinal Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tomas Bata Hospital, Czech RepublicUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia + Peripheral Nerve Block (CA + PNB) | – | –Patients undergoing total knee arthroplasty under general anesthesia combined with a peripheral nerve block. General anesthesia is induced using intravenous and inhalational agents. A peripheral nerve block (most commonly femoral or saphenous) is administered preoperatively to reduce postoperative pain and opioid requirements. This group represents a commonly used multimodal analgesic approach in routine clinical practice. |
| General Anesthesia + Epidural Catheter (CA + EDA) | – | –Patients undergoing total knee arthroplasty under general anesthesia with an epidural catheter placed for intraoperative and postoperative analgesia. General anesthesia is induced using intravenous and inhalational agents. The epidural catheter allows continuous administration of analgesics and individualized dose adjustment to maintain postoperative pain control. This group represents a commonly used technique for providing extended regional analgesia following TKA. |
| Spinal Anesthesia + Peripheral Nerve Block (SA + PNB) | – | –Patients undergoing total knee arthroplasty under spinal anesthesia supplemented with a peripheral nerve block. Spinal anesthesia is administered into the subarachnoid space to provide intraoperative analgesia. A peripheral nerve block (femoral or saphenous) is added to enhance postoperative pain control and reduce the need for systemic analgesics. This combination represents a commonly used multimodal analgesic strategy. |
| Spinal Anesthesia (SA) | – | –Patients receiving spinal anesthesia alone without an additional peripheral nerve block. Spinal anesthesia provides sensory and motor blockade of the lower body during surgery. This group allows evaluation of postoperative pain and analgesic requirements in patients managed with spinal anesthesia as the sole regional technique. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Revision or reoperation of TKA
- ASA score IV or higher
- Refusal to participate or inability to provide informed consent
- GCS ≤ 14
- Limited legal capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Analgesic consumption
Time frame: First 48 hours after surgery
Adverse effects
Time frame: First 48 hours after surgery
Patient satisfaction
Time frame: 48 hours after surgery
Length of hospital stay
Time frame: From the day of surgery (Day 0) through hospital discharge (typically 3-14 days).
Number of participants requiring therapeutic interventions
Time frame: Up to 48 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No. "Individual participant data will not be shared because the study involves sensitive clinical information and no data-sharing plan was included in the ethics committee approval. Data will be used exclusively for the purposes of this study."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain After Total Knee Arthroplasty and Postoperative Pain, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klára Nekvindová, MD, Ph.D. (+420 577 552 111, nekvindova.klara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: 6 hours, 24 hours, and 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.