Total Knee ArthroplastyNCT07124494
Regional Anesthesia in TKA: Impact on Postoperative Joint Motion and Patient Satisfaction
A study testing Regional anethesia in people with Total Knee Arthroplasty and Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This is a single-center, prospective, randomized controlled trial aiming to evaluate the effects of different regional anesthesia/analgesia techniques on postoperative knee range of motion (ROM) and patient satisfaction following total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Postoperative Pain, Regional Anesthesia
- What is being tested?
- Regional anethesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2025to 19 Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for primary total knee arthroplasty
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Accepting neuraxial anesthesia
Who cannot join
- Skin infection at the planned injection site
- Sepsis
- Coagulopathy
- Refusal of neuraxial anesthesia
- Severe hypovolemia
- Demyelinating central nervous system disease
Show all 10Show fewer
- Age under 18 years
- Illiterate in Turkish
- Non-cooperative patients
- Known allergy or hypersensitivity to bupivacaine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yasin Tire
Konya, Meram, 42140
Yasin Tire, 05055367970, dryasintire@hotmail.com
Osman Çiçekler
About this study
Official title: Evaluation of the Effects of Regional Anesthesia Methods Applied in Total Knee Arthroplasty on Joint Range of Motion in the Postoperative Period and Patient Satisfaction
This is a single-center, prospective, randomized controlled trial aiming to evaluate the effects of different regional anesthesia/analgesia techniques on postoperative knee range of motion (ROM) and patient satisfaction following total knee arthroplasty (TKA). Ninety patients undergoing elective TKA under spinal anesthesia will be randomly assigned to one of three groups: 1) spinal anesthesia with epidural catheter, 2) spinal anesthesia followed by adductor canal catheterization, and 3) spinal anesthesia with multimodal intravenous analgesia. The primary outcome is postoperative knee joint ROM measured on postoperative days 1, 2, and 3. Secondary outcomes include patient satisfaction, Oxford Knee Score, postoperative opioid consumption, and VAS scores. The study is conducted at Konya City Hospital and will be completed over a 6-month period.
- Conditions
- Total Knee Arthroplasty, Postoperative Pain, Regional Anesthesia, Knee Range of Motion, Patient Satisfaction
- Being tested
- Regional anethesia
- Medical subject headings
- Pain, Postoperative, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anethesiaProcedure or surgery
This single-center, prospective, randomized controlled trial aims to compare the effects of three different postoperative analgesia techniques following spinal anesthesia in patients undergoing total knee arthroplasty (TKA). The study will assess the impact of combined spinal-epidural anesthesia, adductor canal block, and multimodal intravenous analgesia on postoperative knee range of motion (ROM). Secondary outcomes include patient satisfaction, opioid consumption, Oxford Knee Score (OKS), activity levels, and visual analog scale (VAS) pain scores.
| Study group | Role | What they receive |
|---|---|---|
| Combined Spinal-Epidural Anesthesia | Active comparator | Postoperative analgesia will be provided via epidural catheter with programmed infusion of bupivacaine . Receives: Procedure: Regional anethesia |
| Adductor Canal Block | Active comparator | Ultrasound-guided adductor canal catheter placement and continuous infusion of bupivacaine . Receives: Procedure: Regional anethesia |
| Multimodal Intravenous Analgesia | Sham comparator | Continuous intravenous tramadol infusion with rescue analgesia as required. Receives: Procedure: Regional anethesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Knee Range of Motion (ROM)
Knee joint flexion and extension range of motion will be measured using a standard goniometer by a blinded assessor. Measurements will be performed with the patient in a supine position, ensuring standardized positioning for all participants.
Measured: Postoperative day 1, day 3, day 7, and day 90 after surgery.
Secondary outcomes (5)
Total Opioid Consumption
Cumulative opioid consumption (intravenous and oral) will be recorded and converted to morphine milligram equivalents (MME).
Measured: From the end of surgery to 72 hours postoperatively.
Oxford Knee Score (OKS)
Oxford Knee Score (OKS) questionnaire: Functional outcome will be evaluated using the Oxford Knee Score, a validated 12-item questionnaire assessing pain and physical function.To assess knee pain and functional ability from the patient's perspective.
Number of questions: 12
Score range: 0 to 48
Interpretation:
0 points = worst possible outcome (severe pain and poor function)
48 points = best possible outcome (no pain and full function)
Direction: Higher scores indicate better outcomes
Measured: Preoperatively (baseline) and postoperative day 90.
Visual Analog Scale (VAS) Pain Score
Pain intensity at rest and during movement will be assessed using a 10-cm visual analog scale (0 = no pain, 10 = worst possible pain).
Measured: Postoperative day 1, day 3, and day 7 after surgery.
Incidence of Adverse Events Related to Anesthesia or Analgesia
The occurrence of anesthesia- or analgesia-related complications (e.g., motor weakness, sensory deficits, infection at catheter site, nausea/vomiting, hypotension) will be recorded.
Measured: Intraoperative period and up to 90 days postoperatively.
Patient Satisfaction Score
Patient satisfaction with postoperative analgesia will be assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Measured: Postoperative day 3 and day 90 after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start5 Aug 2025
- Primary completion12 Dec 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Tire, MD, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124494
- Sponsor's protocol ID
- Study Epidural
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Regional Anesthesia Methods Applied in Total Knee Arthroplasty on Joint Range of Motion in the Postoperative Period and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07124494
- Acronym / sponsor ID
- Study Epidural
- Conditions
- Total Knee Arthroplasty, Postoperative Pain, Regional Anesthesia, Knee Range of Motion, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 15 Aug 2025 (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 is a single-center, prospective, randomized controlled trial aiming to evaluate the effects of different regional anesthesia/analgesia techniques on postoperative knee range of motion (ROM) and patient satisfaction following total knee arthroplasty (TKA). Ninety patients undergoing elective TKA under spinal anesthesia will be randomly assigned to one of three groups: 1) spinal anesthesia with epidural catheter, 2) spinal anesthesia followed by adductor canal catheterization, and 3) spinal anesthesia with multimodal intravenous analgesia. The primary outcome is postoperative knee joint ROM measured on postoperative days 1, 2, and 3. Secondary outcomes include patient satisfaction, Oxford Knee Score, postoperative opioid consumption, and VAS scores. The study is conducted at Konya City Hospital and will be completed over a 6-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined Spinal-Epidural Anesthesia | Active comparator | Procedure: Regional anethesiaPostoperative analgesia will be provided via epidural catheter with programmed infusion of bupivacaine . |
| Adductor Canal Block | Active comparator | Procedure: Regional anethesiaUltrasound-guided adductor canal catheter placement and continuous infusion of bupivacaine . |
| Multimodal Intravenous Analgesia | Sham comparator | Procedure: Regional anethesiaContinuous intravenous tramadol infusion with rescue analgesia as required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (10 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional anethesiaThis single-center, prospective, randomized controlled trial aims to compare the effects of three different postoperative analgesia techniques following spinal anesthesia in patients undergoing total knee arthroplasty (TKA). The study will assess the impact of combined spinal-epidural anesthesia, adductor canal block, and multimodal intravenous analgesia on postoperative knee range of motion (ROM). Secondary outcomes include patient satisfaction, opioid consumption, Oxford Knee Score (OKS), activity levels, and visual analog scale (VAS) pain scores. | Procedure or surgery | Adductor Canal Block, Combined Spinal-Epidural Anesthesia, Multimodal Intravenous Analgesia |
Primary outcome
Postoperative Knee Range of Motion (ROM)
Time frame: Postoperative day 1, day 3, day 7, and day 90 after surgery.
Knee joint flexion and extension range of motion will be measured using a standard goniometer by a blinded assessor. Measurements will be performed with the patient in a supine position, ensuring standardized positioning for all participants.
5 secondary outcomes
Total Opioid Consumption
Time frame: From the end of surgery to 72 hours postoperatively.
Oxford Knee Score (OKS)
Time frame: Preoperatively (baseline) and postoperative day 90.
Visual Analog Scale (VAS) Pain Score
Time frame: Postoperative day 1, day 3, and day 7 after surgery.
Incidence of Adverse Events Related to Anesthesia or Analgesia
Time frame: Intraoperative period and up to 90 days postoperatively.
Patient Satisfaction Score
Time frame: Postoperative day 3 and day 90 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 22 Jul 2026.
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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?
A study testing Regional anethesia in people with Total Knee Arthroplasty and Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
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 4 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: looking for participants now, as of the sponsor's last update on 22 Jul 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 Yasin Tire (05055367970, dryasintire@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Knee Range of Motion (ROM) (time frame: Postoperative day 1, day 3, day 7, and day 90 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 22 Jul 2026.